CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

A.T.S. 2200TS Tourniquet Systems recalled by Zimmer Surgical

Zimmer Surgical is recalling A.T.S. 2200TS Tourniquet Systems, Personalized Pressure, distributed nationwide in the US. The recall was initiated on 27 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. Item No. 60400040400, Lot No. 62510548 (Serial Numbers: 2213JAAA, 2213JAAB, 2213JAAC, 2213JAAD, 2213JAAE, 2213JAAF, 2213JAAG, 2213JAAH, 2213JAAJ, 2213JAAK, 2213JAAL, 2213JAAM, 2213JAAN, 2213JAAP, 2213JAAQ, 2213JAAR, 2213JAAS, 2213JAAT, 2213JAAU, 2213JAAW, 2213JABA, 2213JABB, 2213JABC, 2213JABD, 2213JABE, 2213JABF, 2213JABG, 2213JABH); Lot No. 62534445 (Serial Numbers: 2213JABJ, 2213JABK, 2213JABL, 2213JABM, 2213JABN, 2213JABP, 2213JABQ, 2213JABR, 2213JABS, 2213JABT, 2213JABU, 2213JABW, 2213JACA, 2213JACB, 2213JACC, 2213JACD, 2213JACE, 2213JACF, 2213JACG, 2213JACH); Lot No. 62631977 (Serial Numbers: 2214BAAA, 2214BAAB, 2214BAAC, 2214BAAD, 2214BAAE, 2214BAAF, 2214BAAG, 2214BAAH, 2214BAAJ, 2214BAAK, 2214BAAL, 2214BAAM, 2214BAAN, 2214BAAP, 2214BAAQ, 2214BAAR, 2214BAAS, 2214BAAT, 2214BAAU, 2214BAAW); Lot No. 62625059 (Serial Numbers: 2214BABA, 2214BABB, 2214BABC, 2214BABD, 2214BABE, 2214BABF, 2214BABG, 2214BABH, 2214BABJ, 2214BABK, 2214BABL, 2214BABM, 2214BABN, 2214BABP, 2214BABQ, 2214BABR, 2214BABS, 2214BABT, 2214BABU, 2214BABW); Lot No. 62635789 (Serial Numbers: 2214CAAA, 2214CAAB, 2214CAAC, 2214CAAD, 2214CAAE, 2214CAAF, 2214CAAG, 2214CAAH, 2214CAAJ, 2214CAAK, 2214CAAL, 2214CAAM, 2214CAAV, 2214CAAP, 2214CAAQ, 2214CAAR, 2214CAAS, 2214CAAT, 2214CAAU, 2214CAAW); Lot No. 62642067 (Serial Numbers: 2214DAAA, 2214DAAB, 2214DAAC, 2214DAAD, 2214DAAE, 2214DAAF, 2214DAAG, 2214DAAH, 2214DAAJ, 2214DAAK, 2214DAAL, 2214DAAM, 2214DAAN, 2214DAAP, 2214DAAQ, 2214DAAR, 2214DAAS, 2214DAAT, 2214DAAU, 2214DAAW); Lot No. 62642068 (Serial Numbers: 2214EAAA, 2214EAAB, 2214EAAC, 2214EAAD, 2014EAAE, 2214EAAF, 2214EAAG, 2214EAAH, 2214EAAJ, 2214EAAK, 2214EAAL, 2214EAAM, 2214EAAN, 2214EAAP, 2214EAAQ, 2214EAAR, 2214EAAS, 2214EAAT, 2214EAAU, 2214EAAW); Lot No. 62675190 (Serial Numbers: 2214DABA); Lot No. 62732714 (Serial Numbers: 2214FAAA, 2214FAAB, 2214FAAC, 2214FAAD); Lot No. 62727347 (Serial Numbers: 2214FAAE, 2214FAAF, 2214FAAG, 2214FAAH); Lot No. 62727348 (Serial Numbers: 2214FAAJ, 2214FAAK, 2214FAAL); Lot No. 62745916 (Serial Numbers: 2214FAAM, 2214FAAN); Lot No. 62723747 (Serial Numbers: 2214FAAP, 2214FAAQ, 2214FAAR, 2214FAAS, 2214FAAT, 2214FAAU, 2214FAAW, 2214FABA, 2214FABB, 2214FABC, 2214FABD, 2214FABE, 2214FABF, 2214FABG, 2214FABH, 2214FABJ, 2214FABK, 2214FABL, 2214FABM, 2214FABN); Lot No. 62723748 (Serial Numbers: 2214FABP, 2214FABQ, 2214FABR, 2214FABS, 2214FABT, 2214FABU, 2214FABW, 2214FACA, 2214FACB, 2214FACC, 2214FACD, 2214FACE, 2214FACF, 2214FACG, 2214FACH, 2214FACJ, 2214FACK, 2214FACL, 2214FACM, 2214FACN); Lot No. 62758708 (Serial Numbers: 2214GAAA, 2214GAAB, 2214GAAC, 2214GAAD); Lot No. 62758711 (Serial Numbers: 2214GAAE); Lot No. 62760907 (Serial Numbers: 2214GAAF, 2214GAAG); Lot No. 63773338 (Serial Numbers: 2214GAAH, 2214GAAJ, 2214GAAK, 2214GAAL); Lot No. 62773820 (Serial Numbers: 2214GAAM, 2214GAAN); Lot No. 62773463 (Serial Numbers: 2214GAAP); Lot No. 62773471 (Serial Numbers: 2214GAAQ, 2214GAAR, 2214GAAS); Lot No. 62773478 (Serial Numbers: 2214GAAT, 2214GAAU, 2214GAAW, 2214GABA); Lot No. 62773485 (Serial Numbers: 2214GABB, 2214GABC); Lot No. 62748403 (Serial Numbers: 2214GABD, 2214GABE, 2214GABF, 2214GABG, 2214GABH, 2214GABJ, 2214GABK, 2214GABL, 2214GABM, 2214GABN, 2214GABP, 2214GABQ, 2214GABR, 2214GABS, 2214GABT, 2214GABU, 2214GABW, 2214GACA, 2214GACB, 2214GACC); Lot No. 62779664 (Serial Numbers: 2214GACD, 2214GACE); Lot No. 62797832 (Serial Numbers: 2214HAAA, 2214HAAB, 2214HAAC); Lot No. 62797833 (Serial Numbers: 2214HAAD, 2214HAAE, 2214HAAF, 2214HAAG, 2214HAAH); Lot No. 62799449 (Serial Numbers: 2214HAAJ, 2214HAAK, 2214HAAL, 2214HAAM, 2214HAAN, 2214HAAP, 2214HAAQ, 2214HAAR, 2214HAAS, 2214HAAT, 2214HAAU, 2214HAAW, 2214HABA, 2214HABB, 2214HABC, 2214HABD, 2214HABE, 2214HABF, 2214HABG, 2214HABH); Lot No. 62799475 (Serial Numbers: 2214HABJ, 2214HABK, 2214HABL, 2214HABM, 2214HABN, 2214HABP, 2214HABQ, 2214HABR, 2214HABS, 2214HABT, 2214HABU, 2214HABW, 2214HACA, 2214HACB, 2214HACC, 2214HACD, 2214HACE, 2214HACF, 2214HACG, 2214HACH); Lot No. 62824836 (Serial Numbers: 2214IAAA, 2214IAAB, 2214IAAC, 2214IAAD); Lot No. 62838042 (Serial Numbers: 2214IAAE, 2214IAAF, 2214IAAG, 2214IAAH); Lot No. 62812885 (Serial Numbers: 2214IAAJ, 2214IAAK, 2214IAAL, 2214IAAM, 2214IAAN, 2214IAAP, 2214IAAQ, 2214IAAR, 2214IAAS, 2214IAAT, 2214IAAU, 2214IAAW, 2214IABA, 2214IABB, 2214IABC, 2214IABD, 2214IABE, 2214IABF, 2214IABG, 2214IABH); Lot No. 62812853 (Serial Numbers: 2214IABJ, 2214IABK, 2214IABL, 2214IABM, 2214IABN, 2214IABP, 2214IABQ, 2214IABR, 2214IABS, 2214IABT, 2214IABU, 2214IABW, 2214IACA, 2214IACB, 2214IACC, 2214IACD, 2214IACE, 2214IACF, 2214IACG, 2214IACH); Lot No. 62846159 (Serial Numbers: 2214JAAA, 2214JAAB, 2214JAAC); Lot No. 62844916 (Serial Numbers: 2214JAAD); Lot No. 62869981 (Serial Numbers: 2214KAAE, 2214KAAF, 2214KAAG, 2214KAAH, 2214KAAJ); Lot No. 62871639 (Serial Numbers: 2214JAAE, 2214JAAF, 2214JAAG, 2214JAAH); Lot No. 62870928 (Serial Numbers: 2214KAAK, 2214KAAL, 2214KAAM, 2214KAAN, 2214KAAP, 2214KAAQ, 2214KAAR, 2214KAAS, 2214KAAT, 2214KAAU, 2214KAAW, 2214KABA, 2214KABB, 2214KABC, 2214KABD, 2214KABE, 2214KABF, 2214KABG, 2214KABH, 2214KABJ); Lot No. 62877932 (Serial Numbers: 221411110001, 221411110002, 221411110003, 221411110004, 221411110005, 221411110006, 221411110007, 221411110008, 221411110009, 221411110010); Lot No. 62885586 (Serial Numbers: 221411120001, 221411120002, 221411120003, 221411120004, 221411120005); Lot No. 62885587 (Serial Numbers: 221411120006, 221411120007, 221411120008, 221411120009, 221411120010, 221411120011, 221411120012, 221411120013, 221411120014, 221411120015); Lot No. 62895898 (Serial Numbers: 221411200001, 221411200002, 221411200003, 221411200004, 221411200005, 221411200006, 221411200007, 221411200008, 221411200009, 221411200010); Lot No. 62905257 (Serial Numbers: 221411240001); Lot No. 62904091 (Serial Numbers: 221411250001, 221411250002, 221411250003, 221411250004, 221411250005, 221411250006, 221411250007, 221411250008, 221411250009, 221411250010, 221411250011, 221411250012, 221411250013, 221411250014, 221411250015, 221411250016, 221411250017, 221411250018, 221411250019, 221411250020); Lot No. 62904093 (Serial Numbers: 221412010001, 221412010002, 221412010003, 221412010004, 221412010005, 221412010006, 221412010007, 221412010008, 221412010009, 221412010010, 221412010011, 221412010012, 221412010013, 221412010014, 221412010015, 221412010016, 221412010017, 221412010018, 221412010019, 221412010020); Lot No. 62879139 (Serial Numbers: 221412040001, 221412040002, 221412040003, 221412040004, 221412040005); Lot No. 62905838 (Serial Numbers: 221412080001, 221412080002, 221412080003, 221412080004, 221412080005); Lot No. 62895896 (Serial Numbers: 221412120001, 221412120002, 221412120003, 221412120004, 221412120005); Lot No. 62904123 (Serial Numbers: 221412150001, 221412150002, 221412150003, 221412150004, 221412150005, 221412150006, 221412150007, 221412150008, 221412150009, 221412150010, 221412150011, 221412150012, 221412150013, 221412150014, 221412150015, 221412150016, 221412150017, 221412150018, 221412150019, 221412150020); Lot No. 62932244 (Serial Numbers: 221412180001, 221412180002, 221412180003, 221412180004, 221412180005, 221412180006, 221412180007, 221412180008, 221412180009, 221412180010, 221412180011, 221412180012, 221412180013, 221412180014, 221412180015, 221412180016, 221412180017, 221412180018, 221412180019, 221412180020); Lot No. 62935217 (Serial Numbers: 221412190001, 221412190002, 221412190003, 221412190004, 221412190005); Lot No. 62937693 (Serial Numbers: 221501050001, 221501050002, 221501050003, 221501050004, 221501050005); Lot No. 62945082 (Serial Numbers: 221501080001, 221501080002, 221501080003, 221501080004, 221501080005); Lot No. 62945086 (Serial Numbers: 201501080006, 201501080007, 201501080008); Lot No. 62932650 (Serial Numbers: 221503090001, 221503090002, 221503090003, 221503090004, 221503090005, 221503090006, 221503090007, 221503090008, 221503090009, 221503090010, 221503090011, 221503090012, 221503090013, 221503090014, 221503090015, 221503090016, 221503090017, 221503090018, 221503090019, 22150309002); Lot No. 62961804 (Serial Numbers: 221503120001, 221503120002, 221503120003, 221503120004, 221503120005, 221503120006, 221503120007, 221503120008, 221503120009, 221503120010, 221503120011, 221503120012, 221503120013, 221503120014, 221503120015, 221503120016, 221503120017, 221503120018, 221503120019, 221503120020); Lot No. 62976480 (Serial Numbers: 221503190001, 221503190002, 221503190003, 221503190004, 221503190005, 221503190006, 221503190007, 221503190008, 221503190009, 221503190010, 221503190011, 221503190012, 221503190013, 221503190014, 221503190015, 221503190016, 221503190017, 221503190018, 221503190019, 221503190020); Lot No. 62976481 (Serial Numbers: 221503250001, 221503250002, 221503250003, 221503250004, 221503250005, 221503250006, 221503250007, 221503250008, 221503250009, 221503250010, 221503250011, 221503250012, 221503250013, 221503250014, 221503250015, 221503250016, 221503250017, 221503250018, 221503250019, 221503250020); Lot No. 63026460 (Serial Numbers: 221503270001, 221503270002, 221503270003, 221503270004, 221503270005); Lot No. 63007852 (Serial Numbers: 221504080001, 221504080002, 221504080003, 221504080004, 221504080005, 221504080006, 221504080007, 221504080008, 221504080009, 221504080010, 221504080011, 221504080012, 221504080013, 221504080014, 221504080015, 221504080016, 221504080017, 221504080018, 221504080019, 221504080020 Lot No. 63042181 (Serial Numbers: 221504140001, 221504140002, 221504140003, 221504140004, 221504140005); Lot No. 63042182 (Serial Numbers: 221504140006, 221504140007, 221504140008, 221504140009, 221504140010); Lot No. 63007853 (Serial Numbers: 221504140011, 221504140012, 221504140013, 221504140014, 221504140015, 221504140016, 221504140017, 221504140018, 221504140019, 221504140020, 221504140021, 221504140022, 221504140023, 221504140024, 221504140025, 221504140026, 221504140027, 221504140028, 221504140029, 221504140030); Lot No. 63042179 (Serial Numbers: 221504160001, 221504160002, 221504160003); Lot No. 63042184 (Serial Numbers: 221504220001, 221504220002, 221504220003, 221504220004, 221504220005); Lot No. 63037252 (Serial Numbers: 221504250001, 221504250002, 221504250003, 221504250004, 221504250005, 221504250006, 221504250007, 221504250008, 221504250009, 221504250010, 221504250011, 221504250012, 221504250013, 221504250014, 221504250015, 221504250016, 221504250017, 221504250018, 221504250019, 221504250020); Lot No. 63042180 (Serial Numbers: 221504280001, 221504280002, 221504280003, 221504280004, 221504280005, 221504280006, 221504280007, 221504280008, 221504280009, 221504280010, 221504280011, 221504280012, 221504280013, 221504280014, 221504280015, 221504280016, 221504280017, 221504280018, 221504280019, 221504280020); Lot No. 63042183 (Serial Numbers: 221505110001, 221505110002, 221505110003, 221505110004, 221505110005); Lot No. 63037254 (Serial Numbers: 221505120001, 221505120002, 221505120003, 221505120004, 221505120005, 221505120006, 221505120007, 221505120008, 221505120009, 221505120010, 221505120011, 221505120012, 221505120013, 221505120014, 221505120015, 221505120016, 221505120017, 221505120018, 221505120019, 221505120020); Lot No. 63092209 (Serial Numbers: 221506030001, 221506030002, 221506030003); Lot No. 63092210 (Serial Numbers: 221506050001, 221506050002, 221506050003, 221506050004, 221506050005); Lot No. 63072301 (Serial Numbers: 221506100001, 221506100002, 221506100003, 221506100004, 221506100005, 221506100006, 221506100007, 221506100008, 221506100009, 221506100010, 221506100011, 221506100012, 221506100013, 221506100014, 221506100015, 221506100016, 221506100017, 221506100018, 221506100019, 221506100020); Lot No. 63103587 (Serial Numbers: 221506130001, 221506130002, 221506130003, 221506130004, 221506130005, 221506130006, 221506130007, 221506130008, 221506130009, 221506130010, 221506130011, 221506130012, 221506130013, 221506130014, 221506130015); Lot No. 63072324 (Serial Numbers: 221506170001, 221506170002, 221506170003, 221506170004, 221506170005, 221506170006, 221506170007, 221506170008, 221506170009, 221506170010, 221506170011, 221506170012, 221506170013, 221506170014, 221506170015, 221506170016, 221506170017, 221506170018, 221506170019, 221506170020); Lot No. 63103164 (Serial Numbers: 221506170021, 221506170022, 221506170023); Lot No. 63072352 (Serial Numbers: 221506200001, 221506200002, 221506200003, 221506200004, 221506200005, 221506200006, 221506200007, 221506200008, 221506200009, 221506200010, 221506200011, 221506200012, 221506200013, 221506200014, 221506200015, 221506200016, 221506200017, 221506200018, 221506200019, 221506200020); Lot No. 63096468 (Serial Numbers: 221507150001, 221507150002, 221507150003, 221507150004, 221507150005, 221507150006, 221507150007, 221507150008, 221507150009, 221507150010, 221507150011, 221507150012, 221507150013, 221507150014, 221507150015, 221507150016, 221507150017, 221507150018, 221507150019, 221507150020); Lot No. 63109655 (Serial Numbers: 221507160001, 221507160002, 221507160003); Lot No. 63103590 (Serial Numbers: 221507210001, 221507210002, 221507210003, 221507210004, 221507210005, 221507210006, 221507210007, 221507210008, 221507210009, 221507210010, 221507210011, 221507210012, 221507210013, 221507210014, 221507210015); Lot No. 63109651 (Serial Numbers: 221507280001, 221507280002, 221507280003, 221507280004, 221507280005, 221507280006, 221507280007, 221507280008, 221507280009, 221507280010); Lot No. 63116357 (Serial Numbers: 221507290001, 221507290002, 221507290003, 221507290004, 221507290005, 221507290006, 221507290007, 221507290008, 221507290009, 221507290010, 221507290011, 221507290012, 221507290013, 221507290014, 221507290015, 221507290016, 221507290017, 221507290018, 221507290019, 221507290020); Lot No. 63123305 (Serial Numbers: 221508040001, 221508040002, 221508040003, 221508040004, 221508040005, 221508040006, 221508040007, 221508040008, 221508040009, 221508040010, 221508040011, 221508040012, 221508040013, 221508040014, 221508040015, 221508040016, 221508040017, 221508040018, 221508040019, 221508040020); Lot No. 63138553 (Serial Numbers: 221508260001, 221508260002, 221508260003, 221508260004, 221508260005, 221508260006, 221508260007, 221508260008, 221508260009, 221508260010, 221508260011, 221508260012, 221508260013, 221508260014, 221508260015, 221508260016, 221508260017, 221508260018, 221508260019, 221508260020); Lot No. 63138631 (Serial Numbers: 221509090001, 221509090002, 221509090003, 221509090004, 221509090005, 221509090006, 221509090007, 221509090008, 221509090009, 221509090010, 221509090011, 221509090012, 221509090013, 221509090014, 221509090015, 221509090016, 221509090017, 221509090018, 221509090019, 221509090020); Lot No. 63171089 (Serial Numbers: 221509240001, 221509240002, 221509240003, 221509240004, 221509240005, 221509240006, 221509240007, 221509240008, 221509240009, 221509240010, 221509240011, 221509240012, 221509240013, 221509240014, 221509240015, 221509240016, 221509240017, 221509240018, 221509240019, 221509240020); Lot No. 63202480 (Serial Numbers: 221510120001, 221510120002, 221510120003, 221510120004, 221510120005); Lot No. 63202478 (Serial Numbers: 221510220001, 221510220002, 221510220003, 221510220004, 221510220005, 221510220006, 221510220007, 221510220008, 221510220009, 221510220010, 221510220011, 221510220012, 221510220013, 221510220014, 221510220015, 221510220016, 221510220017, 221510220018, 221510220019, 221510220020); Lot No. 63234563 (Serial Numbers: 221511230001, 221511230002, 221511230003, 221511230004, 221511230005); Lot No. 63234565 (Serial Numbers: 221512020001, 221512020002, 221512020003, 221512020004, 221512020005); Lot No. 63212407 (Serial Numbers: 221512070001, 221512070002, 221512070003, 221512070004, 221512070005, 221512070006, 221512070007, 221512070008, 221512070009, 221512070010, 221512070011, 221512070012, 221512070013, 221512070014, 221512070015, 221512070016, 221512070017, 221512070018, 221512070019, 221512070020); Lot No. 63245752 (Serial Numbers: 221512160001, 221512160002, 221512160003, 221512160004, 221512160005, 221512160006, 221512160007); Lot No. 63253256 (Serial Numbers: 221512180001, 221512180002, 221512180003, 221512180004, 221512180005); Lot No. 63247425 (Serial Numbers: 221601060001, 221601060002, 221601060003, 221601060004, 221601060005, 221601060006, 221601060007, 221601060008, 221601060009, 221601060010, 221601060011, 221601060012, 221601060013, 221601060014, 221601060015, 221601060016, 221601060017, 221601060018, 221601060019, 221601060020); Lot No. 63526287 (Serial Numbers: 221612140001, 221612140002, 221612140003, 221612140004, 221612140005, 221612140006, 221612140007, 221612140008, 221612140009, 221612140010, 221612140011, 221612140012, 221612140013, 221612140014, 221612140015, 221612140016, 221612140017, 221612140018, 221612140019, 221612140020); Lot No. 63531691 (Serial Numbers: 221612150001, 221612150002, 221612150003, 221612150004, 221612150005, 221612150006, 221612150007); Lot No. 63526321 (Serial Numbers: 221612170001, 221612170002, 221612170003, 221612170004, 221612170005, 221612170006, 221612170007, 221612170008, 221612170009, 221612170010, 221612170011, 221612170012, 221612170013, 221612170014, 221612170015, 221612170016, 221612170017, 221612170018, 221612170019, 221612170020); Lot No. 63261584 (Serial Numbers: 221601070001, 221601070002, 221601070003, 221601070004, 221601070005); Lot No. 63264374 (Serial Numbers: 221601110001, 221601110002, 221601110003, 221601110004, 221601110005, 221601110006, 221601110007, 221601110008, 221601110009, 221601110010, 221601110011, 221601110012, 221601110013, 221601110014, 221601110015, 221601110016, 221601110017, 221601110018, 221601110019, 221601110020); Lot No. 63265280 (Serial Numbers: 221601140001, 221601140002, 221601140003, 221601140004, 221601140005, 221601140006, 221601140007); Lot No. 63257987 (Serial Numbers: 221601180001, 221601180002, 221601180003, 221601180004, 221601180005, 221601180006, 221601180007, 221601180008, 221601180009, 221601180010, 221601180011, 221601180012, 221601180013, 221601180014, 221601180015, 221601180016, 221601180017, 221601180018, 221601180019, 221601180020); Lot No. 63271202 (Serial Numbers: 221601220001, 221601220002, 221601220003, 221601220004, 221601220005); Lot No. 63258039 (Serial Numbers: 221602060001, 221602060002, 221602060003, 221602060004, 221602060005, 221602060006, 221602060007, 221602060008, 221602060009, 221602060010, 221602060011, 221602060012, 221602060013, 221602060014, 221602060015, 221602060016, 221602060017, 221602060018, 221602060019, 221602060020); Lot No. 63278388 (Serial Numbers: 221602150001, 221602150002, 221602150003, 221602150004, 221602150005, 221602150006, 221602150007, 221602150008, 221602150009, 221602150010, 221602150011, 221602150012, 221602150013, 221602150014, 221602150015, 221602150016, 221602150017, 221602150018, 221602150019, 221602150020); Lot No. 63278436 (Serial Numbers: 221602240001, 221602240002, 221602240003, 221602240004, 221602240005, 221602240006, 221602240007, 221602240008, 221602240009, 221602240010, 221602240011, 221602240012, 221602240013, 221602240014, 221602240015, 221602240016, 221602240017, 221602240018, 221602240019, 221602240020); Lot No. 63314121 (Serial Numbers: 221603090001, 221603090002, 221603090003); Lot No. 63314118 (Serial Numbers: 221603110001, 221603110002, 221603110003); Lot No. 63324625 (Serial Numbers: 221603220001, 221603220002, 221603220003); Lot No. 63336959 (Serial Numbers: 221603300001, 221603300002, 221603300003, 221603300004, 221603300005, 221603300006, 221603300007, 221603300008, 221603300009, 221603300010); Lot No. 63314042 (Serial Numbers: 221603300011, 221603300012, 221603300013, 221603300014, 221603300015, 221603300016, 221603300017, 221603300018, 221603300019, 221603300020, 221603300021, 221603300022, 221603300023, 221603300024, 221603300025, 221603300026, 221603300027, 221603300028, 221603300029, 221603300030); Lot No. 63341344 (Serial Numbers: 221604040001, 221604040002, 221604040003, 221604040004, 221604040005); Lot No. 63341346 (Serial Numbers: 221604050001, 221604050002, 221604050003, 221604050004, 221604050005, 221604050006, 221604050007, 221604050008, 221604050009, 221604050010); Lot No. 63314117 (Serial Numbers: 221604220001, 221604220002, 221604220003, 221604220004, 221604220005, 221604220006, 221604220007, 221604220008, 221604220009, 221604220010, 221604220011, 221604220012, 221604220013, 221604220014, 221604220015, 221604220016, 221604220017, 221604220018, 221604220019, 221604220020); Lot No. 63352349 (Serial Numbers: 221604250001, 221604250002, 221604250003); Lot No. 63339440 (Serial Numbers: 221605020001, 221605020002, 221605020003, 221605020004, 221605020005, 221605020006, 221605020007, 221605020008, 221605020009, 221605020010, 221605020011, 221605020012, 221605020013, 221605020014, 221605020015, 221605020016, 221605020017, 221605020018, 221605020019, 221605020020); Lot No. 63343366 (Serial Numbers: 221605060001, 221605060002, 221605060003, 221605060004, 221605060005, 221605060006, 221605060007, 221605060008, 221605060009, 221605060010, 221605060011, 221605060012, 221605060013, 221605060014, 221605060015, 221605060016, 221605060017, 221605060018, 221605060019, 221605060020, 221605060021, 221605060022); Lot No. 63352347 (Serial Numbers: 221605110001, 221605110002, 221605110003, 221605110004, 221605110005); Lot No. 63339497 (Serial Numbers: 221605120001, 221605120002, 221605120003, 221605120004, 221605120005, 221605120006, 221605120007, 221605120008, 221605120009, 221605120010, 221605120011, 221605120012, 221605120013, 221605120014, 221605120015, 221605120016, 221605120017, 221605120018, 221605120019, 221605120020); Lot No. 63378855 (Serial Numbers: 221606020001, 221606020002, 221606020003); Lot No. 63369605 (Serial Numbers: 221606110001, 221606110002, 221606110003, 221606110004, 221606110005, 221606110006, 221606110007, 221606110008, 221606110009, 221606110010, 221606110011, 221606110012, 221606110013, 221606110014, 221606110015, 221606110016, 221606110017, 221606110018, 221606110019, 221606110020); Lot No. 63403010 (Serial Numbers: 221606110021, 221606110022, 221606110023); Lot No. 63403012 (Serial Numbers: 221606150001, 221606150002, 221606150003, 221606150004, 221606150005, 221606150006, 221606150007, 221606150008); Lot No. 63403026 (Serial Numbers: 221606210001, 221606210002, 221606210003, 221606210004, 221606210005, 221606210006, 221606210007, 221606210008, 221606210009, 221606210010, 221606210011, 221606210012, 221606210013, 221606210014, 221606210015, 221606210016, 221606210017, 221606210018, 221606210019, 221606210020); Lot No. 63403009 (Serial Numbers: 221606220001, 221606220002, 221606220003); Lot No. 63403024 (Serial Numbers: 221606230001, 221606230002, 221606230003, 221606230004, 221606230005, 221606230006, 221606230007, 221606230008, 221606230009, 221606230010, 221606230011, 221606230012, 221606230013, 221606230014, 221606230015, 221606230016, 221606230017, 221606230018, 221606230019, 221606230020); Lot No. 63403025 (Serial Numbers: 221606240001, 221606240002, 221606240003, 221606240004, 221606240005, 221606240006, 221606240007, 221606240008, 221606240009, 221606240010); Lot No. 63403017 (Serial Numbers: 221606240011, 221606240012, 221606240013, 221606240014, 221606240015); Lot No. 63394148 (Serial Numbers: 221606290001, 221606290002, 221606290003, 221606290004, 221606290005, 221606290006, 221606290007, 221606290008, 221606290009, 221606290010, 221606290011, 221606290012, 221606290013, 221606290014, 221606290015, 221606290016, 221606290017, 221606290018, 221606290019, 221606290020); Lot No. 63410582 (Serial Numbers: 221607050001, 221607050002, 221607050003, 221607050004, 221607050005, 221607050006, 221607050007, 221607050008, 221607050009, 221607050010, 221607050011, 221607050012, 221607050013, 221607050014, 221607050015); Lot No. 63422767 (Serial Numbers: 221607080001, 221607080002, 221607080003, 221607080004, 221607080005, 221607080006, 221607080007, 221607080008, 221607080009, 221607080010, 221607080011, 221607080012, 221607080013, 221607080014, 221607080015, 221607080016, 221607080017, 221607080018, 221607080019, 221607080020); Lot No. 63410583 (Serial Numbers: 221607210001, 221607210002, 221607210003, 221607210004, 221607210005, 221607210006, 221607210007, 221607210008, 221607210009, 221607210010); Lot No. 63410585 (Serial Numbers: 221607220001, 221607220002, 221607220003, 221607220004, 221607220005, 221607220006, 221607220007, 221607220008, 221607220009, 221607220010); Lot No. 63394176 (Serial Numbers: 221607260001, 221607260002, 221607260003, 221607260004, 221607260005, 221607260006, 221607260007, 221607260008, 221607260009, 221607260010, 221607260011, 221607260012, 221607260013, 221607260014, 221607260015, 221607260016, 221607260017, 221607260018, 221607260019, 221607260020); Lot No. 63430499 (Serial Numbers: 221608080001, 221608080002, 221608080003, 221608080004, 221608080005, 221608080006, 221608080007, 221608080008, 221608080009, 221608080010, 221608080011, 221608080012, 221608080013, 221608080014, 221608080015, 221608080016, 221608080017, 221608080018, 221608080019, 221608080020); Lot No. 63437710 (Serial Numbers: 221608120001, 221608120002, 221608120003, 221608120004, 221608120005); Lot No. 63436338 (Serial Numbers: 221608160001, 221608160002, 221608160003, 221608160004, 221608160005); Lot No. 63445193 (Serial Numbers: 221608170001, 221608170002, 221608170003, 221608170004, 221608170005, 221608170006, 221608170007, 221608170008, 221608170009, 221608170010, 221608170011, 221608170012, 221608170013, 221608170014, 221608170015, 221608170016, 221608170017, 221608170018, 221608170019, 221608170020); Lot No. 63430540 (Serial Numbers: 221608190001, 221608190002, 221608190003, 221608190004, 221608190005, 221608190006, 221608190007, 221608190008, 221608190009, 221608190010, 221608190011, 221608190012, 221608190013, 221608190014, 221608190015, 221608190016, 221608190017, 221608190018, 221608190019, 221608190020); Lot No. 63445194 (Serial Numbers: 221608230001, 221608230002, 221608230003, 221608230004, 221608230005, 221608230006, 221608230007, 221608230008, 221608230009, 221608230010, 221608230011, 221608230012, 221608230013, 221608230014, 221608230015, 221608230016, 221608230017, 221608230018, 221608230019, 221608230020); Lot No. 63455066 (Serial Numbers: 221609010001, 221609010002, 221609010003, 221609010004, 221609010005, 221609010006, 221609010007, 221609010008, 221609010009, 221609010010, 221609010011, 221609010012, 221609010013, 221609010014, 221609010015, 221609010016, 221609010017, 221609010018, 221609010019, 221609010020); Lot No. 63474281 (Serial Numbers: 221609080001, 221609080002, 221609080003, 221609080004, 221609080005, 221609080006, 221609080007, 221609080008, 221609080009, 221609080010, 221609080011, 221609080012, 221609080013, 221609080014, 221609080015, 221609080016, 221609080017, 221609080018, 221609080019, 221609080020); Lot No. 63474283 (Serial Numbers: 221609080021, 221609080022, 221609080023, 221609080024, 221609080025, 221609080026); Lot No. 63474284 (Serial Numbers: 221609150001, 221609150002, 221609150003, 221609150004, 221609150005, 221609150006, 221609150007, 221609150008); Lot No. 63474287 (Serial Numbers: 221609210001, 221609210002, 221609210003, 221609210004, 221609210005, 221609210006, 221609210007, 221609210008, 221609210009, 221609210010); Lot No. 63474285 (Serial Numbers: 221610010001, 221610010002, 221610010003, 221610010004, 221610010005, 221610010006, 221610010007, 221610010008, 221610010009, 221610010010, 221610010011, 221610010012, 221610010013, 221610010014, 221610010015); Lot No. 63455098 (Serial Numbers: 221610050001, 221610050002, 221610050003, 221610050004, 221610050005, 221610050006, 221610050007, 221610050008, 221610050009, 221610050010, 221610050011, 221610050012, 221610050013, 221610050014, 221610050015, 221610050016, 221610050017, 221610050018, 221610050019, 221610050020); Lot No. 63474282 (Serial Numbers: 221610110001, 221610110002, 221610110003, 221610110004, 221610110005, 221610110006, 221610110007, 221610110008, 221610110009, 221610110010, 221610110011, 221610110012, 221610110013, 221610110014, 221610110015, 221610110016, 221610110017, 221610110018, 221610110019, 221610110020); Lot No. 63484747 (Serial Numbers: 221610140001, 221610140002, 221610140003, 221610140004, 221610140005); Lot No. 63482404 (Serial Numbers: 221610180001, 221610180002, 221610180003, 221610180004, 221610180005, 221610180006, 221610180007, 221610180008, 221610180009, 221610180010, 221610180011, 221610180012, 221610180013, 221610180014, 221610180015, 221610180016, 221610180017, 221610180018, 221610180019, 221610180020); Lot No. 63482405 (Serial Numbers: 221610200001, 221610200002, 221610200003, 221610200004, 221610200005, 221610200006, 221610200007, 221610200008, 221610200009, 221610200010, 221610200011, 221610200012, 221610200013, 221610200014, 221610200015, 221610200016, 221610200017, 221610200018, 221610200019, 221610200020); Lot No. 63482408 (Serial Numbers: 221611210001, 221611210002, 221611210003, 221611210004, 221611210005, 221611210006, 221611210007, 221611210008, 221611210009, 221611210010, 221611210011,221611210012, 221611210013, 221611210014, 221611210015, 221611210016, 221611210017, 221611210018, 221611210019, 221611210020); Lot No. 63501470 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501471 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501459 (Serial Numbers: 221611280001, 221611280002, 221611280003, 221611280004, 221611280005, 221611280006, 221611280007, 221611280008, 221611280009, 221611280010, 221611280011, 221611280012, 221611280013, 221611280014, 221611280015, 221611280016, 221611280017, 221611280018, 221611280019, 221611280020); Lot No. 63501486 (Serial Numbers: 221612020001, 221612020002, 221612020003, 221612020004, 221612020005, 221612020006, 221612020007, 221612020008, 221612020009, 221612020010, 221612020011, 221612020012, 221612020013, 221612020014, 221612020015, 221612020016, 221612020017, 221612020018, 221612020019, 221612020020); Lot No. 63501469 (Serial Numbers: 221612030001, 221612030002, 221612030003, 221612030004, 221612030005, 221612030006, 221612030007, 221612030008, 221612030009, 221612030010, 221612030011, 221612030012, 221612030013, 221612030014, 221612030015, 221612030016, 221612030017, 221612030018); Lot No. 63531693 (Serial Numbers: 221612050001, 221612050002, 221612050003, 221612050004, 221612050005); Lot No. 63501509 (Serial Numbers: 221612070001, 221612070002, 221612070003, 221612070004, 221612070005, 221612070006, 221612070007, 221612070008, 221612070009, 221612070010, 221612070011, 221612070012, 221612070013, 221612070014, 221612070015, 221612070016, 221612070017, 221612070018, 221612070019, 221612070020); Lot No. 63501547 (Serial Numbers: 221612100001, 221612100002, 221612100003, 221612100004, 221612100005, 221612100006, 221612100007, 221612100008, 221612100009, 221612100010, 221612100011, 221612100012, 221612100013, 221612100014, 221612100015, 221612100016, 221612100017, 221612100018, 221612100019, 221612100020); Lot No. 63501493 (Serial Numbers: 221612130001, 221612130002, 221612130003, 221612130004, 221612130005, 221612130006, 221612130007, 221612130008)

Quantity recalled8,231 devices total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0613-2018
FDA event ID: 78759
Recalling firm: Zimmer Surgical, Dover, OH
Classification: Class II
Status: Terminated
Recall initiated: 27 Jul 2017
FDA classified: 14 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

27 Jul 2017	Recall initiated by company
14 Feb 2018	Classified by FDA	+202 days
21 Feb 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

Product as listed by the FDA

A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

Where it was distributed

Worldwide Distribution: US (nationwide) to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Guam; and countries to Australia, Brazil, Canada, Chile, China, Denmark, Dominican, El Salvador, England, Finland, France, Hong Kong, India, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Singapore, Sweden, Taiwan, and Thailand..

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

Which lots are affected?

Lot No. Item No. 60400040400, Lot No. 62510548 (Serial Numbers: 2213JAAA, 2213JAAB, 2213JAAC, 2213JAAD, 2213JAAE, 2213JAAF, 2213JAAG, 2213JAAH, 2213JAAJ, 2213JAAK, 2213JAAL, 2213JAAM, 2213JAAN, 2213JAAP, 2213JAAQ, 2213JAAR, 2213JAAS, 2213JAAT, 2213JAAU, 2213JAAW, 2213JABA, 2213JABB, 2213JABC, 2213JABD, 2213JABE, 2213JABF, 2213JABG, 2213JABH); Lot No. 62534445 (Serial Numbers: 2213JABJ, 2213JABK, 2213JABL, 2213JABM, 2213JABN, 2213JABP, 2213JABQ, 2213JABR, 2213JABS, 2213JABT, 2213JABU, 2213JABW, 2213JACA, 2213JACB, 2213JACC, 2213JACD, 2213JACE, 2213JACF, 2213JACG, 2213JACH); Lot No. 62631977 (Serial Numbers: 2214BAAA, 2214BAAB, 2214BAAC, 2214BAAD, 2214BAAE, 2214BAAF, 2214BAAG, 2214BAAH, 2214BAAJ, 2214BAAK, 2214BAAL, 2214BAAM, 2214BAAN, 2214BAAP, 2214BAAQ, 2214BAAR, 2214BAAS, 2214BAAT, 2214BAAU, 2214BAAW); Lot No. 62625059 (Serial Numbers: 2214BABA, 2214BABB, 2214BABC, 2214BABD, 2214BABE, 2214BABF, 2214BABG, 2214BABH, 2214BABJ, 2214BABK, 2214BABL, 2214BABM, 2214BABN, 2214BABP, 2214BABQ, 2214BABR, 2214BABS, 2214BABT, 2214BABU, 2214BABW); Lot No. 62635789 (Serial Numbers: 2214CAAA, 2214CAAB, 2214CAAC, 2214CAAD, 2214CAAE, 2214CAAF, 2214CAAG, 2214CAAH, 2214CAAJ, 2214CAAK, 2214CAAL, 2214CAAM, 2214CAAV, 2214CAAP, 2214CAAQ, 2214CAAR, 2214CAAS, 2214CAAT, 2214CAAU, 2214CAAW); Lot No. 62642067 (Serial Numbers: 2214DAAA, 2214DAAB, 2214DAAC, 2214DAAD, 2214DAAE, 2214DAAF, 2214DAAG, 2214DAAH, 2214DAAJ, 2214DAAK, 2214DAAL, 2214DAAM, 2214DAAN, 2214DAAP, 2214DAAQ, 2214DAAR, 2214DAAS, 2214DAAT, 2214DAAU, 2214DAAW); Lot No. 62642068 (Serial Numbers: 2214EAAA, 2214EAAB, 2214EAAC, 2214EAAD, 2014EAAE, 2214EAAF, 2214EAAG, 2214EAAH, 2214EAAJ, 2214EAAK, 2214EAAL, 2214EAAM, 2214EAAN, 2214EAAP, 2214EAAQ, 2214EAAR, 2214EAAS, 2214EAAT, 2214EAAU, 2214EAAW); Lot No. 62675190 (Serial Numbers: 2214DABA); Lot No. 62732714 (Serial Numbers: 2214FAAA, 2214FAAB, 2214FAAC, 2214FAAD); Lot No. 62727347 (Serial Numbers: 2214FAAE, 2214FAAF, 2214FAAG, 2214FAAH); Lot No. 62727348 (Serial Numbers: 2214FAAJ, 2214FAAK, 2214FAAL); Lot No. 62745916 (Serial Numbers: 2214FAAM, 2214FAAN); Lot No. 62723747 (Serial Numbers: 2214FAAP, 2214FAAQ, 2214FAAR, 2214FAAS, 2214FAAT, 2214FAAU, 2214FAAW, 2214FABA, 2214FABB, 2214FABC, 2214FABD, 2214FABE, 2214FABF, 2214FABG, 2214FABH, 2214FABJ, 2214FABK, 2214FABL, 2214FABM, 2214FABN); Lot No. 62723748 (Serial Numbers: 2214FABP, 2214FABQ, 2214FABR, 2214FABS, 2214FABT, 2214FABU, 2214FABW, 2214FACA, 2214FACB, 2214FACC, 2214FACD, 2214FACE, 2214FACF, 2214FACG, 2214FACH, 2214FACJ, 2214FACK, 2214FACL, 2214FACM, 2214FACN); Lot No. 62758708 (Serial Numbers: 2214GAAA, 2214GAAB, 2214GAAC, 2214GAAD); Lot No. 62758711 (Serial Numbers: 2214GAAE); Lot No. 62760907 (Serial Numbers: 2214GAAF, 2214GAAG); Lot No. 63773338 (Serial Numbers: 2214GAAH, 2214GAAJ, 2214GAAK, 2214GAAL); Lot No. 62773820 (Serial Numbers: 2214GAAM, 2214GAAN); Lot No. 62773463 (Serial Numbers: 2214GAAP); Lot No. 62773471 (Serial Numbers: 2214GAAQ, 2214GAAR, 2214GAAS); Lot No. 62773478 (Serial Numbers: 2214GAAT, 2214GAAU, 2214GAAW, 2214GABA); Lot No. 62773485 (Serial Numbers: 2214GABB, 2214GABC); Lot No. 62748403 (Serial Numbers: 2214GABD, 2214GABE, 2214GABF, 2214GABG, 2214GABH, 2214GABJ, 2214GABK, 2214GABL, 2214GABM, 2214GABN, 2214GABP, 2214GABQ, 2214GABR, 2214GABS, 2214GABT, 2214GABU, 2214GABW, 2214GACA, 2214GACB, 2214GACC); Lot No. 62779664 (Serial Numbers: 2214GACD, 2214GACE); Lot No. 62797832 (Serial Numbers: 2214HAAA, 2214HAAB, 2214HAAC); Lot No. 62797833 (Serial Numbers: 2214HAAD, 2214HAAE, 2214HAAF, 2214HAAG, 2214HAAH); Lot No. 62799449 (Serial Numbers: 2214HAAJ, 2214HAAK, 2214HAAL, 2214HAAM, 2214HAAN, 2214HAAP, 2214HAAQ, 2214HAAR, 2214HAAS, 2214HAAT, 2214HAAU, 2214HAAW, 2214HABA, 2214HABB, 2214HABC, 2214HABD, 2214HABE, 2214HABF, 2214HABG, 2214HABH); Lot No. 62799475 (Serial Numbers: 2214HABJ, 2214HABK, 2214HABL, 2214HABM, 2214HABN, 2214HABP, 2214HABQ, 2214HABR, 2214HABS, 2214HABT, 2214HABU, 2214HABW, 2214HACA, 2214HACB, 2214HACC, 2214HACD, 2214HACE, 2214HACF, 2214HACG, 2214HACH); Lot No. 62824836 (Serial Numbers: 2214IAAA, 2214IAAB, 2214IAAC, 2214IAAD); Lot No. 62838042 (Serial Numbers: 2214IAAE, 2214IAAF, 2214IAAG, 2214IAAH); Lot No. 62812885 (Serial Numbers: 2214IAAJ, 2214IAAK, 2214IAAL, 2214IAAM, 2214IAAN, 2214IAAP, 2214IAAQ, 2214IAAR, 2214IAAS, 2214IAAT, 2214IAAU, 2214IAAW, 2214IABA, 2214IABB, 2214IABC, 2214IABD, 2214IABE, 2214IABF, 2214IABG, 2214IABH); Lot No. 62812853 (Serial Numbers: 2214IABJ, 2214IABK, 2214IABL, 2214IABM, 2214IABN, 2214IABP, 2214IABQ, 2214IABR, 2214IABS, 2214IABT, 2214IABU, 2214IABW, 2214IACA, 2214IACB, 2214IACC, 2214IACD, 2214IACE, 2214IACF, 2214IACG, 2214IACH); Lot No. 62846159 (Serial Numbers: 2214JAAA, 2214JAAB, 2214JAAC); Lot No. 62844916 (Serial Numbers: 2214JAAD); Lot No. 62869981 (Serial Numbers: 2214KAAE, 2214KAAF, 2214KAAG, 2214KAAH, 2214KAAJ); Lot No. 62871639 (Serial Numbers: 2214JAAE, 2214JAAF, 2214JAAG, 2214JAAH); Lot No. 62870928 (Serial Numbers: 2214KAAK, 2214KAAL, 2214KAAM, 2214KAAN, 2214KAAP, 2214KAAQ, 2214KAAR, 2214KAAS, 2214KAAT, 2214KAAU, 2214KAAW, 2214KABA, 2214KABB, 2214KABC, 2214KABD, 2214KABE, 2214KABF, 2214KABG, 2214KABH, 2214KABJ); Lot No. 62877932 (Serial Numbers: 221411110001, 221411110002, 221411110003, 221411110004, 221411110005, 221411110006, 221411110007, 221411110008, 221411110009, 221411110010); Lot No. 62885586 (Serial Numbers: 221411120001, 221411120002, 221411120003, 221411120004, 221411120005); Lot No. 62885587 (Serial Numbers: 221411120006, 221411120007, 221411120008, 221411120009, 221411120010, 221411120011, 221411120012, 221411120013, 221411120014, 221411120015); Lot No. 62895898 (Serial Numbers: 221411200001, 221411200002, 221411200003, 221411200004, 221411200005, 221411200006, 221411200007, 221411200008, 221411200009, 221411200010); Lot No. 62905257 (Serial Numbers: 221411240001); Lot No. 62904091 (Serial Numbers: 221411250001, 221411250002, 221411250003, 221411250004, 221411250005, 221411250006, 221411250007, 221411250008, 221411250009, 221411250010, 221411250011, 221411250012, 221411250013, 221411250014, 221411250015, 221411250016, 221411250017, 221411250018, 221411250019, 221411250020); Lot No. 62904093 (Serial Numbers: 221412010001, 221412010002, 221412010003, 221412010004, 221412010005, 221412010006, 221412010007, 221412010008, 221412010009, 221412010010, 221412010011, 221412010012, 221412010013, 221412010014, 221412010015, 221412010016, 221412010017, 221412010018, 221412010019, 221412010020); Lot No. 62879139 (Serial Numbers: 221412040001, 221412040002, 221412040003, 221412040004, 221412040005); Lot No. 62905838 (Serial Numbers: 221412080001, 221412080002, 221412080003, 221412080004, 221412080005); Lot No. 62895896 (Serial Numbers: 221412120001, 221412120002, 221412120003, 221412120004, 221412120005); Lot No. 62904123 (Serial Numbers: 221412150001, 221412150002, 221412150003, 221412150004, 221412150005, 221412150006, 221412150007, 221412150008, 221412150009, 221412150010, 221412150011, 221412150012, 221412150013, 221412150014, 221412150015, 221412150016, 221412150017, 221412150018, 221412150019, 221412150020); Lot No. 62932244 (Serial Numbers: 221412180001, 221412180002, 221412180003, 221412180004, 221412180005, 221412180006, 221412180007, 221412180008, 221412180009, 221412180010, 221412180011, 221412180012, 221412180013, 221412180014, 221412180015, 221412180016, 221412180017, 221412180018, 221412180019, 221412180020); Lot No. 62935217 (Serial Numbers: 221412190001, 221412190002, 221412190003, 221412190004, 221412190005); Lot No. 62937693 (Serial Numbers: 221501050001, 221501050002, 221501050003, 221501050004, 221501050005); Lot No. 62945082 (Serial Numbers: 221501080001, 221501080002, 221501080003, 221501080004, 221501080005); Lot No. 62945086 (Serial Numbers: 201501080006, 201501080007, 201501080008); Lot No. 62932650 (Serial Numbers: 221503090001, 221503090002, 221503090003, 221503090004, 221503090005, 221503090006, 221503090007, 221503090008, 221503090009, 221503090010, 221503090011, 221503090012, 221503090013, 221503090014, 221503090015, 221503090016, 221503090017, 221503090018, 221503090019, 22150309002); Lot No. 62961804 (Serial Numbers: 221503120001, 221503120002, 221503120003, 221503120004, 221503120005, 221503120006, 221503120007, 221503120008, 221503120009, 221503120010, 221503120011, 221503120012, 221503120013, 221503120014, 221503120015, 221503120016, 221503120017, 221503120018, 221503120019, 221503120020); Lot No. 62976480 (Serial Numbers: 221503190001, 221503190002, 221503190003, 221503190004, 221503190005, 221503190006, 221503190007, 221503190008, 221503190009, 221503190010, 221503190011, 221503190012, 221503190013, 221503190014, 221503190015, 221503190016, 221503190017, 221503190018, 221503190019, 221503190020); Lot No. 62976481 (Serial Numbers: 221503250001, 221503250002, 221503250003, 221503250004, 221503250005, 221503250006, 221503250007, 221503250008, 221503250009, 221503250010, 221503250011, 221503250012, 221503250013, 221503250014, 221503250015, 221503250016, 221503250017, 221503250018, 221503250019, 221503250020); Lot No. 63026460 (Serial Numbers: 221503270001, 221503270002, 221503270003, 221503270004, 221503270005); Lot No. 63007852 (Serial Numbers: 221504080001, 221504080002, 221504080003, 221504080004, 221504080005, 221504080006, 221504080007, 221504080008, 221504080009, 221504080010, 221504080011, 221504080012, 221504080013, 221504080014, 221504080015, 221504080016, 221504080017, 221504080018, 221504080019, 221504080020 Lot No. 63042181 (Serial Numbers: 221504140001, 221504140002, 221504140003, 221504140004, 221504140005); Lot No. 63042182 (Serial Numbers: 221504140006, 221504140007, 221504140008, 221504140009, 221504140010); Lot No. 63007853 (Serial Numbers: 221504140011, 221504140012, 221504140013, 221504140014, 221504140015, 221504140016, 221504140017, 221504140018, 221504140019, 221504140020, 221504140021, 221504140022, 221504140023, 221504140024, 221504140025, 221504140026, 221504140027, 221504140028, 221504140029, 221504140030); Lot No. 63042179 (Serial Numbers: 221504160001, 221504160002, 221504160003); Lot No. 63042184 (Serial Numbers: 221504220001, 221504220002, 221504220003, 221504220004, 221504220005); Lot No. 63037252 (Serial Numbers: 221504250001, 221504250002, 221504250003, 221504250004, 221504250005, 221504250006, 221504250007, 221504250008, 221504250009, 221504250010, 221504250011, 221504250012, 221504250013, 221504250014, 221504250015, 221504250016, 221504250017, 221504250018, 221504250019, 221504250020); Lot No. 63042180 (Serial Numbers: 221504280001, 221504280002, 221504280003, 221504280004, 221504280005, 221504280006, 221504280007, 221504280008, 221504280009, 221504280010, 221504280011, 221504280012, 221504280013, 221504280014, 221504280015, 221504280016, 221504280017, 221504280018, 221504280019, 221504280020); Lot No. 63042183 (Serial Numbers: 221505110001, 221505110002, 221505110003, 221505110004, 221505110005); Lot No. 63037254 (Serial Numbers: 221505120001, 221505120002, 221505120003, 221505120004, 221505120005, 221505120006, 221505120007, 221505120008, 221505120009, 221505120010, 221505120011, 221505120012, 221505120013, 221505120014, 221505120015, 221505120016, 221505120017, 221505120018, 221505120019, 221505120020); Lot No. 63092209 (Serial Numbers: 221506030001, 221506030002, 221506030003); Lot No. 63092210 (Serial Numbers: 221506050001, 221506050002, 221506050003, 221506050004, 221506050005); Lot No. 63072301 (Serial Numbers: 221506100001, 221506100002, 221506100003, 221506100004, 221506100005, 221506100006, 221506100007, 221506100008, 221506100009, 221506100010, 221506100011, 221506100012, 221506100013, 221506100014, 221506100015, 221506100016, 221506100017, 221506100018, 221506100019, 221506100020); Lot No. 63103587 (Serial Numbers: 221506130001, 221506130002, 221506130003, 221506130004, 221506130005, 221506130006, 221506130007, 221506130008, 221506130009, 221506130010, 221506130011, 221506130012, 221506130013, 221506130014, 221506130015); Lot No. 63072324 (Serial Numbers: 221506170001, 221506170002, 221506170003, 221506170004, 221506170005, 221506170006, 221506170007, 221506170008, 221506170009, 221506170010, 221506170011, 221506170012, 221506170013, 221506170014, 221506170015, 221506170016, 221506170017, 221506170018, 221506170019, 221506170020); Lot No. 63103164 (Serial Numbers: 221506170021, 221506170022, 221506170023); Lot No. 63072352 (Serial Numbers: 221506200001, 221506200002, 221506200003, 221506200004, 221506200005, 221506200006, 221506200007, 221506200008, 221506200009, 221506200010, 221506200011, 221506200012, 221506200013, 221506200014, 221506200015, 221506200016, 221506200017, 221506200018, 221506200019, 221506200020); Lot No. 63096468 (Serial Numbers: 221507150001, 221507150002, 221507150003, 221507150004, 221507150005, 221507150006, 221507150007, 221507150008, 221507150009, 221507150010, 221507150011, 221507150012, 221507150013, 221507150014, 221507150015, 221507150016, 221507150017, 221507150018, 221507150019, 221507150020); Lot No. 63109655 (Serial Numbers: 221507160001, 221507160002, 221507160003); Lot No. 63103590 (Serial Numbers: 221507210001, 221507210002, 221507210003, 221507210004, 221507210005, 221507210006, 221507210007, 221507210008, 221507210009, 221507210010, 221507210011, 221507210012, 221507210013, 221507210014, 221507210015); Lot No. 63109651 (Serial Numbers: 221507280001, 221507280002, 221507280003, 221507280004, 221507280005, 221507280006, 221507280007, 221507280008, 221507280009, 221507280010); Lot No. 63116357 (Serial Numbers: 221507290001, 221507290002, 221507290003, 221507290004, 221507290005, 221507290006, 221507290007, 221507290008, 221507290009, 221507290010, 221507290011, 221507290012, 221507290013, 221507290014, 221507290015, 221507290016, 221507290017, 221507290018, 221507290019, 221507290020); Lot No. 63123305 (Serial Numbers: 221508040001, 221508040002, 221508040003, 221508040004, 221508040005, 221508040006, 221508040007, 221508040008, 221508040009, 221508040010, 221508040011, 221508040012, 221508040013, 221508040014, 221508040015, 221508040016, 221508040017, 221508040018, 221508040019, 221508040020); Lot No. 63138553 (Serial Numbers: 221508260001, 221508260002, 221508260003, 221508260004, 221508260005, 221508260006, 221508260007, 221508260008, 221508260009, 221508260010, 221508260011, 221508260012, 221508260013, 221508260014, 221508260015, 221508260016, 221508260017, 221508260018, 221508260019, 221508260020); Lot No. 63138631 (Serial Numbers: 221509090001, 221509090002, 221509090003, 221509090004, 221509090005, 221509090006, 221509090007, 221509090008, 221509090009, 221509090010, 221509090011, 221509090012, 221509090013, 221509090014, 221509090015, 221509090016, 221509090017, 221509090018, 221509090019, 221509090020); Lot No. 63171089 (Serial Numbers: 221509240001, 221509240002, 221509240003, 221509240004, 221509240005, 221509240006, 221509240007, 221509240008, 221509240009, 221509240010, 221509240011, 221509240012, 221509240013, 221509240014, 221509240015, 221509240016, 221509240017, 221509240018, 221509240019, 221509240020); Lot No. 63202480 (Serial Numbers: 221510120001, 221510120002, 221510120003, 221510120004, 221510120005); Lot No. 63202478 (Serial Numbers: 221510220001, 221510220002, 221510220003, 221510220004, 221510220005, 221510220006, 221510220007, 221510220008, 221510220009, 221510220010, 221510220011, 221510220012, 221510220013, 221510220014, 221510220015, 221510220016, 221510220017, 221510220018, 221510220019, 221510220020); Lot No. 63234563 (Serial Numbers: 221511230001, 221511230002, 221511230003, 221511230004, 221511230005); Lot No. 63234565 (Serial Numbers: 221512020001, 221512020002, 221512020003, 221512020004, 221512020005); Lot No. 63212407 (Serial Numbers: 221512070001, 221512070002, 221512070003, 221512070004, 221512070005, 221512070006, 221512070007, 221512070008, 221512070009, 221512070010, 221512070011, 221512070012, 221512070013, 221512070014, 221512070015, 221512070016, 221512070017, 221512070018, 221512070019, 221512070020); Lot No. 63245752 (Serial Numbers: 221512160001, 221512160002, 221512160003, 221512160004, 221512160005, 221512160006, 221512160007); Lot No. 63253256 (Serial Numbers: 221512180001, 221512180002, 221512180003, 221512180004, 221512180005); Lot No. 63247425 (Serial Numbers: 221601060001, 221601060002, 221601060003, 221601060004, 221601060005, 221601060006, 221601060007, 221601060008, 221601060009, 221601060010, 221601060011, 221601060012, 221601060013, 221601060014, 221601060015, 221601060016, 221601060017, 221601060018, 221601060019, 221601060020); Lot No. 63526287 (Serial Numbers: 221612140001, 221612140002, 221612140003, 221612140004, 221612140005, 221612140006, 221612140007, 221612140008, 221612140009, 221612140010, 221612140011, 221612140012, 221612140013, 221612140014, 221612140015, 221612140016, 221612140017, 221612140018, 221612140019, 221612140020); Lot No. 63531691 (Serial Numbers: 221612150001, 221612150002, 221612150003, 221612150004, 221612150005, 221612150006, 221612150007); Lot No. 63526321 (Serial Numbers: 221612170001, 221612170002, 221612170003, 221612170004, 221612170005, 221612170006, 221612170007, 221612170008, 221612170009, 221612170010, 221612170011, 221612170012, 221612170013, 221612170014, 221612170015, 221612170016, 221612170017, 221612170018, 221612170019, 221612170020); Lot No. 63261584 (Serial Numbers: 221601070001, 221601070002, 221601070003, 221601070004, 221601070005); Lot No. 63264374 (Serial Numbers: 221601110001, 221601110002, 221601110003, 221601110004, 221601110005, 221601110006, 221601110007, 221601110008, 221601110009, 221601110010, 221601110011, 221601110012, 221601110013, 221601110014, 221601110015, 221601110016, 221601110017, 221601110018, 221601110019, 221601110020); Lot No. 63265280 (Serial Numbers: 221601140001, 221601140002, 221601140003, 221601140004, 221601140005, 221601140006, 221601140007); Lot No. 63257987 (Serial Numbers: 221601180001, 221601180002, 221601180003, 221601180004, 221601180005, 221601180006, 221601180007, 221601180008, 221601180009, 221601180010, 221601180011, 221601180012, 221601180013, 221601180014, 221601180015, 221601180016, 221601180017, 221601180018, 221601180019, 221601180020); Lot No. 63271202 (Serial Numbers: 221601220001, 221601220002, 221601220003, 221601220004, 221601220005); Lot No. 63258039 (Serial Numbers: 221602060001, 221602060002, 221602060003, 221602060004, 221602060005, 221602060006, 221602060007, 221602060008, 221602060009, 221602060010, 221602060011, 221602060012, 221602060013, 221602060014, 221602060015, 221602060016, 221602060017, 221602060018, 221602060019, 221602060020); Lot No. 63278388 (Serial Numbers: 221602150001, 221602150002, 221602150003, 221602150004, 221602150005, 221602150006, 221602150007, 221602150008, 221602150009, 221602150010, 221602150011, 221602150012, 221602150013, 221602150014, 221602150015, 221602150016, 221602150017, 221602150018, 221602150019, 221602150020); Lot No. 63278436 (Serial Numbers: 221602240001, 221602240002, 221602240003, 221602240004, 221602240005, 221602240006, 221602240007, 221602240008, 221602240009, 221602240010, 221602240011, 221602240012, 221602240013, 221602240014, 221602240015, 221602240016, 221602240017, 221602240018, 221602240019, 221602240020); Lot No. 63314121 (Serial Numbers: 221603090001, 221603090002, 221603090003); Lot No. 63314118 (Serial Numbers: 221603110001, 221603110002, 221603110003); Lot No. 63324625 (Serial Numbers: 221603220001, 221603220002, 221603220003); Lot No. 63336959 (Serial Numbers: 221603300001, 221603300002, 221603300003, 221603300004, 221603300005, 221603300006, 221603300007, 221603300008, 221603300009, 221603300010); Lot No. 63314042 (Serial Numbers: 221603300011, 221603300012, 221603300013, 221603300014, 221603300015, 221603300016, 221603300017, 221603300018, 221603300019, 221603300020, 221603300021, 221603300022, 221603300023, 221603300024, 221603300025, 221603300026, 221603300027, 221603300028, 221603300029, 221603300030); Lot No. 63341344 (Serial Numbers: 221604040001, 221604040002, 221604040003, 221604040004, 221604040005); Lot No. 63341346 (Serial Numbers: 221604050001, 221604050002, 221604050003, 221604050004, 221604050005, 221604050006, 221604050007, 221604050008, 221604050009, 221604050010); Lot No. 63314117 (Serial Numbers: 221604220001, 221604220002, 221604220003, 221604220004, 221604220005, 221604220006, 221604220007, 221604220008, 221604220009, 221604220010, 221604220011, 221604220012, 221604220013, 221604220014, 221604220015, 221604220016, 221604220017, 221604220018, 221604220019, 221604220020); Lot No. 63352349 (Serial Numbers: 221604250001, 221604250002, 221604250003); Lot No. 63339440 (Serial Numbers: 221605020001, 221605020002, 221605020003, 221605020004, 221605020005, 221605020006, 221605020007, 221605020008, 221605020009, 221605020010, 221605020011, 221605020012, 221605020013, 221605020014, 221605020015, 221605020016, 221605020017, 221605020018, 221605020019, 221605020020); Lot No. 63343366 (Serial Numbers: 221605060001, 221605060002, 221605060003, 221605060004, 221605060005, 221605060006, 221605060007, 221605060008, 221605060009, 221605060010, 221605060011, 221605060012, 221605060013, 221605060014, 221605060015, 221605060016, 221605060017, 221605060018, 221605060019, 221605060020, 221605060021, 221605060022); Lot No. 63352347 (Serial Numbers: 221605110001, 221605110002, 221605110003, 221605110004, 221605110005); Lot No. 63339497 (Serial Numbers: 221605120001, 221605120002, 221605120003, 221605120004, 221605120005, 221605120006, 221605120007, 221605120008, 221605120009, 221605120010, 221605120011, 221605120012, 221605120013, 221605120014, 221605120015, 221605120016, 221605120017, 221605120018, 221605120019, 221605120020); Lot No. 63378855 (Serial Numbers: 221606020001, 221606020002, 221606020003); Lot No. 63369605 (Serial Numbers: 221606110001, 221606110002, 221606110003, 221606110004, 221606110005, 221606110006, 221606110007, 221606110008, 221606110009, 221606110010, 221606110011, 221606110012, 221606110013, 221606110014, 221606110015, 221606110016, 221606110017, 221606110018, 221606110019, 221606110020); Lot No. 63403010 (Serial Numbers: 221606110021, 221606110022, 221606110023); Lot No. 63403012 (Serial Numbers: 221606150001, 221606150002, 221606150003, 221606150004, 221606150005, 221606150006, 221606150007, 221606150008); Lot No. 63403026 (Serial Numbers: 221606210001, 221606210002, 221606210003, 221606210004, 221606210005, 221606210006, 221606210007, 221606210008, 221606210009, 221606210010, 221606210011, 221606210012, 221606210013, 221606210014, 221606210015, 221606210016, 221606210017, 221606210018, 221606210019, 221606210020); Lot No. 63403009 (Serial Numbers: 221606220001, 221606220002, 221606220003); Lot No. 63403024 (Serial Numbers: 221606230001, 221606230002, 221606230003, 221606230004, 221606230005, 221606230006, 221606230007, 221606230008, 221606230009, 221606230010, 221606230011, 221606230012, 221606230013, 221606230014, 221606230015, 221606230016, 221606230017, 221606230018, 221606230019, 221606230020); Lot No. 63403025 (Serial Numbers: 221606240001, 221606240002, 221606240003, 221606240004, 221606240005, 221606240006, 221606240007, 221606240008, 221606240009, 221606240010); Lot No. 63403017 (Serial Numbers: 221606240011, 221606240012, 221606240013, 221606240014, 221606240015); Lot No. 63394148 (Serial Numbers: 221606290001, 221606290002, 221606290003, 221606290004, 221606290005, 221606290006, 221606290007, 221606290008, 221606290009, 221606290010, 221606290011, 221606290012, 221606290013, 221606290014, 221606290015, 221606290016, 221606290017, 221606290018, 221606290019, 221606290020); Lot No. 63410582 (Serial Numbers: 221607050001, 221607050002, 221607050003, 221607050004, 221607050005, 221607050006, 221607050007, 221607050008, 221607050009, 221607050010, 221607050011, 221607050012, 221607050013, 221607050014, 221607050015); Lot No. 63422767 (Serial Numbers: 221607080001, 221607080002, 221607080003, 221607080004, 221607080005, 221607080006, 221607080007, 221607080008, 221607080009, 221607080010, 221607080011, 221607080012, 221607080013, 221607080014, 221607080015, 221607080016, 221607080017, 221607080018, 221607080019, 221607080020); Lot No. 63410583 (Serial Numbers: 221607210001, 221607210002, 221607210003, 221607210004, 221607210005, 221607210006, 221607210007, 221607210008, 221607210009, 221607210010); Lot No. 63410585 (Serial Numbers: 221607220001, 221607220002, 221607220003, 221607220004, 221607220005, 221607220006, 221607220007, 221607220008, 221607220009, 221607220010); Lot No. 63394176 (Serial Numbers: 221607260001, 221607260002, 221607260003, 221607260004, 221607260005, 221607260006, 221607260007, 221607260008, 221607260009, 221607260010, 221607260011, 221607260012, 221607260013, 221607260014, 221607260015, 221607260016, 221607260017, 221607260018, 221607260019, 221607260020); Lot No. 63430499 (Serial Numbers: 221608080001, 221608080002, 221608080003, 221608080004, 221608080005, 221608080006, 221608080007, 221608080008, 221608080009, 221608080010, 221608080011, 221608080012, 221608080013, 221608080014, 221608080015, 221608080016, 221608080017, 221608080018, 221608080019, 221608080020); Lot No. 63437710 (Serial Numbers: 221608120001, 221608120002, 221608120003, 221608120004, 221608120005); Lot No. 63436338 (Serial Numbers: 221608160001, 221608160002, 221608160003, 221608160004, 221608160005); Lot No. 63445193 (Serial Numbers: 221608170001, 221608170002, 221608170003, 221608170004, 221608170005, 221608170006, 221608170007, 221608170008, 221608170009, 221608170010, 221608170011, 221608170012, 221608170013, 221608170014, 221608170015, 221608170016, 221608170017, 221608170018, 221608170019, 221608170020); Lot No. 63430540 (Serial Numbers: 221608190001, 221608190002, 221608190003, 221608190004, 221608190005, 221608190006, 221608190007, 221608190008, 221608190009, 221608190010, 221608190011, 221608190012, 221608190013, 221608190014, 221608190015, 221608190016, 221608190017, 221608190018, 221608190019, 221608190020); Lot No. 63445194 (Serial Numbers: 221608230001, 221608230002, 221608230003, 221608230004, 221608230005, 221608230006, 221608230007, 221608230008, 221608230009, 221608230010, 221608230011, 221608230012, 221608230013, 221608230014, 221608230015, 221608230016, 221608230017, 221608230018, 221608230019, 221608230020); Lot No. 63455066 (Serial Numbers: 221609010001, 221609010002, 221609010003, 221609010004, 221609010005, 221609010006, 221609010007, 221609010008, 221609010009, 221609010010, 221609010011, 221609010012, 221609010013, 221609010014, 221609010015, 221609010016, 221609010017, 221609010018, 221609010019, 221609010020); Lot No. 63474281 (Serial Numbers: 221609080001, 221609080002, 221609080003, 221609080004, 221609080005, 221609080006, 221609080007, 221609080008, 221609080009, 221609080010, 221609080011, 221609080012, 221609080013, 221609080014, 221609080015, 221609080016, 221609080017, 221609080018, 221609080019, 221609080020); Lot No. 63474283 (Serial Numbers: 221609080021, 221609080022, 221609080023, 221609080024, 221609080025, 221609080026); Lot No. 63474284 (Serial Numbers: 221609150001, 221609150002, 221609150003, 221609150004, 221609150005, 221609150006, 221609150007, 221609150008); Lot No. 63474287 (Serial Numbers: 221609210001, 221609210002, 221609210003, 221609210004, 221609210005, 221609210006, 221609210007, 221609210008, 221609210009, 221609210010); Lot No. 63474285 (Serial Numbers: 221610010001, 221610010002, 221610010003, 221610010004, 221610010005, 221610010006, 221610010007, 221610010008, 221610010009, 221610010010, 221610010011, 221610010012, 221610010013, 221610010014, 221610010015); Lot No. 63455098 (Serial Numbers: 221610050001, 221610050002, 221610050003, 221610050004, 221610050005, 221610050006, 221610050007, 221610050008, 221610050009, 221610050010, 221610050011, 221610050012, 221610050013, 221610050014, 221610050015, 221610050016, 221610050017, 221610050018, 221610050019, 221610050020); Lot No. 63474282 (Serial Numbers: 221610110001, 221610110002, 221610110003, 221610110004, 221610110005, 221610110006, 221610110007, 221610110008, 221610110009, 221610110010, 221610110011, 221610110012, 221610110013, 221610110014, 221610110015, 221610110016, 221610110017, 221610110018, 221610110019, 221610110020); Lot No. 63484747 (Serial Numbers: 221610140001, 221610140002, 221610140003, 221610140004, 221610140005); Lot No. 63482404 (Serial Numbers: 221610180001, 221610180002, 221610180003, 221610180004, 221610180005, 221610180006, 221610180007, 221610180008, 221610180009, 221610180010, 221610180011, 221610180012, 221610180013, 221610180014, 221610180015, 221610180016, 221610180017, 221610180018, 221610180019, 221610180020); Lot No. 63482405 (Serial Numbers: 221610200001, 221610200002, 221610200003, 221610200004, 221610200005, 221610200006, 221610200007, 221610200008, 221610200009, 221610200010, 221610200011, 221610200012, 221610200013, 221610200014, 221610200015, 221610200016, 221610200017, 221610200018, 221610200019, 221610200020); Lot No. 63482408 (Serial Numbers: 221611210001, 221611210002, 221611210003, 221611210004, 221611210005, 221611210006, 221611210007, 221611210008, 221611210009, 221611210010, 221611210011,221611210012, 221611210013, 221611210014, 221611210015, 221611210016, 221611210017, 221611210018, 221611210019, 221611210020); Lot No. 63501470 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501471 (Serial Numbers: 221611210021, 221611210022, 221611210023, 221611210024, 221611210025); Lot No. 63501459 (Serial Numbers: 221611280001, 221611280002, 221611280003, 221611280004, 221611280005, 221611280006, 221611280007, 221611280008, 221611280009, 221611280010, 221611280011, 221611280012, 221611280013, 221611280014, 221611280015, 221611280016, 221611280017, 221611280018, 221611280019, 221611280020); Lot No. 63501486 (Serial Numbers: 221612020001, 221612020002, 221612020003, 221612020004, 221612020005, 221612020006, 221612020007, 221612020008, 221612020009, 221612020010, 221612020011, 221612020012, 221612020013, 221612020014, 221612020015, 221612020016, 221612020017, 221612020018, 221612020019, 221612020020); Lot No. 63501469 (Serial Numbers: 221612030001, 221612030002, 221612030003, 221612030004, 221612030005, 221612030006, 221612030007, 221612030008, 221612030009, 221612030010, 221612030011, 221612030012, 221612030013, 221612030014, 221612030015, 221612030016, 221612030017, 221612030018); Lot No. 63531693 (Serial Numbers: 221612050001, 221612050002, 221612050003, 221612050004, 221612050005); Lot No. 63501509 (Serial Numbers: 221612070001, 221612070002, 221612070003, 221612070004, 221612070005, 221612070006, 221612070007, 221612070008, 221612070009, 221612070010, 221612070011, 221612070012, 221612070013, 221612070014, 221612070015, 221612070016, 221612070017, 221612070018, 221612070019, 221612070020); Lot No. 63501547 (Serial Numbers: 221612100001, 221612100002, 221612100003, 221612100004, 221612100005, 221612100006, 221612100007, 221612100008, 221612100009, 221612100010, 221612100011, 221612100012, 221612100013, 221612100014, 221612100015, 221612100016, 221612100017, 221612100018, 221612100019, 221612100020); Lot No. 63501493 (Serial Numbers: 221612130001, 221612130002, 221612130003, 221612130004, 221612130005, 221612130006, 221612130007, 221612130008)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Zimmer Surgical

All 26

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled	Zimmer Surgical	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled	Zimmer Surgical	Sterility	Nationwide
4 Feb 2026Device	CLASS II	Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled	Zimmer Surgical	Device Malfunction	OH
4 Feb 2026Device	CLASS II	Zimmer Tourniquet Systems A.T.S.¿ 3200TS Tourniquet Systems recalled	Zimmer Surgical	Device Malfunction	OH
24 Dec 2025Device	CLASS II	Zimmer Dermatome recalled by Zimmer Surgical	Zimmer Surgical	Other	OH

Other Surgical Instruments recalls

All 3,891

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide