CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report

Product 41 consists of all product under product recalled

Zimmer Manufacturing is recalling Product 41 consists of all product under, distributed nationwide in the US. The recall was initiated on 11 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot no.: 61644212 61792526 61815349 61828043 61850984 61890427 61921816 61934581 61969233 62017629 62093240 62093241 62093243 62171309 62197649 62197650 62299114 62318135 62318136 62318137 62318138 62318150 61644213 61815350 61828044 61873638 61934582 62002277 62067293 62075869 62160328 62213281 62263054 62263055 62267127 62267128 62267129 62267130 62267131 62267133 62267135 62267136 62267137 62267138 62267139 62267140 62294218 62294225 62294226 62294228 61803056 61873639 61895894 61912747 61912749 62227211 62299118 62299127 62299132 62299134 61764436 62213282 62322533 62322535 62322537 62322612 62322616 62322620 62322623 62322637 62227216 62322865 62322866 62322867 62322868 62322870 62322871 62322875 62322881 62322883 62322885 62322881N 62322881P 61982440 62054519 62075872 37107680 62338654 62338655 62058551 62075873 61897704 62054521 62124276 62218067 61786382 62002271 62067291 62075871 62263052 61644206 61828034 61858125 61921813 61982441 62054523 62054524 62075870 62213267 62263057 62263058 62263060 62263062 62311830 62311838 62213267N 61629787 61644207 61700053 61815343 61878336 61906727 61982442 62031691 62067292 62172859 62172863 62172866 62172869 62172875 62172881 62285701 62285703 62285704 62285705 62285706 62285707 62285719 62285735 62285736 62285737 62293594 62293596 62293598 62293601 62293603 62293604 37107683 61644208 61658563 61700054 61815344 61828036 61858129 61890423 61906729 61964352 62031692 62085434 62171298 62171299 62172882 62172883 62172901 62172902 62172903 62172922 62172924 62311864 62311865 62311867 62311868 62317534 62317535 61644209 61666067 61774943 61792524 61803051 61828037 61849828 61849829 61890424 61906732 61906734 61921814 61951257 61951258 61982444 62002272 62002273 62171301 62219423 62219424 62219425 61644210 61700056 61774945 61774946 61774949 61782868 61792525 61815347 61815348 61828039 61850979 61858126 61890425 61897705 61921815 61934577 61934578 61951259 61951260 62002275 62002276 62031695 62037785 62037786 62037787 62146201 62171303 62171304 62213272 62219426 62227191 62253341 62253342 62253343 62253358 62253360 62054520 61774950 61774951 61798414 61798417 61798418 61803052 61803053 61828041 61850980 61850981 61873634 61873635 61890426 61897706 61906723 61906725 61951261 61951262 62017624 62017625 62017626 62031698 62095808 62171307 62197644 62197645 62213280 62219427 62240213 62240216 62240218 62240221 62240223 62240224 62318171 62318172 62318173 62318176 62318177 62318180 62318182 62318183 62318185 62318186 62318188 62318189 62318191 62318193 61644211 61666114 61686799 61700058 61774953 61774958 61798423 61803054 61803055 61828042 61850982 61858127 61873637 61897707 61934579 61951263 61964353 62008238 62017627 62090097 62090099 62090101 62146213 62197646 62197647 62227192 62227193 61780306 61977803 62054525 62106378 61951264 62090102 62157180 62093248 62171310 61927737 61969231 62031700 61969232 62137458 61815351 61878377 62141642 61815352 62046412 62165416

Quantity recalled6059

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-1139-2016
FDA event ID: 72900
Recalling firm: Zimmer Manufacturing, Mercedita, PR
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2016
FDA classified: 12 Mar 2016
Reported: 23 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

11 Jan 2016	Recall initiated by company
12 Mar 2016	Classified by FDA	+61 days
23 Mar 2016	Published in enforcement report	+11 days

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

Reason for recall

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Product 41 consists of all product under product code: KTT and same usage: Item no: 119301042 LAG SCR 12.7D X 100MM STA 119301045 LAG SCR 12.7D X 105MM STA 119301047 LAG SCR 12.7D X 110MM STA 119301050 LAG SCR 12.7D X 115MM STA 119301052 LAG SCR 12.7D X 120MM STA 119301055 LAG SCR 12.7D X 125MM STA 119301057 LAG SCR 12.7D X 130MM STA 119301060 LAG SCR 12.7D X 135MM STA 119301062 LAG SCR 12.7D X 140MM STA 119301070 LAG SCR 12.7D X 155MM STA 119301020 LAG SCR 12.7D X 55MM STAN 119301022 LAG SCR 12.7D X 60MM STAN 119301025 LAG SCR 12.7D X 65MM STAN 119301027 LAG SCR 12.7D X 70MM STAN 119301030 LAG SCR 12.7D X 75MM STAN 119301032 LAG SCR 12.7D X 80MM STAN 119301035 LAG SCR 12.7D X 85MM STAN 119300537 LAG SCR 12.7D X 90MM SHOR 119301037 LAG SCR 12.7D X 90MM STAN 119301040 LAG SCR 12.7D X 95MM STAN 119301542 LAG SCR 15.8D X 100MM LAR 119301545 LAG SCR 15.8D X 105MM LAR 119301547 LAG SCR 15.8D X 110MM LAR 119301550 LAG SCR 15.8D X 115MM LAR 119301552 LAG SCR 15.8D X 120MM LAR 119301555 LAG SCR 15.8D X 125MM LAR 119301557 LAG SCR 15.8D X 130MM LAR 119301520 LAG SCR 15.8D X 55MM LARG 119301522 LAG SCR 15.8D X 60MM LARG 119301525 LAG SCR 15.8D X 65MM LARG 119301532 LAG SCR 15.8D X 80MM LARG 119301535 LAG SCR 15.8D X 85MM LARG 119301537 LAG SCR 15.8D X 90MM LARG Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Which lots are affected?

lot no.: 61644212 61792526 61815349 61828043 61850984 61890427 61921816 61934581 61969233 62017629 62093240 62093241 62093243 62171309 62197649 62197650 62299114 62318135 62318136 62318137 62318138 62318150 61644213 61815350 61828044 61873638 61934582 62002277 62067293 62075869 62160328 62213281 62263054 62263055 62267127 62267128 62267129 62267130 62267131 62267133 62267135 62267136 62267137 62267138 62267139 62267140 62294218 62294225 62294226 62294228 61803056 61873639 61895894 61912747 61912749 62227211 62299118 62299127 62299132 62299134 61764436 62213282 62322533 62322535 62322537 62322612 62322616 62322620 62322623 62322637 62227216 62322865 62322866 62322867 62322868 62322870 62322871 62322875 62322881 62322883 62322885 62322881N 62322881P 61982440 62054519 62075872 37107680 62338654 62338655 62058551 62075873 61897704 62054521 62124276 62218067 61786382 62002271 62067291 62075871 62263052 61644206 61828034 61858125 61921813 61982441 62054523 62054524 62075870 62213267 62263057 62263058 62263060 62263062 62311830 62311838 62213267N 61629787 61644207 61700053 61815343 61878336 61906727 61982442 62031691 62067292 62172859 62172863 62172866 62172869 62172875 62172881 62285701 62285703 62285704 62285705 62285706 62285707 62285719 62285735 62285736 62285737 62293594 62293596 62293598 62293601 62293603 62293604 37107683 61644208 61658563 61700054 61815344 61828036 61858129 61890423 61906729 61964352 62031692 62085434 62171298 62171299 62172882 62172883 62172901 62172902 62172903 62172922 62172924 62311864 62311865 62311867 62311868 62317534 62317535 61644209 61666067 61774943 61792524 61803051 61828037 61849828 61849829 61890424 61906732 61906734 61921814 61951257 61951258 61982444 62002272 62002273 62171301 62219423 62219424 62219425 61644210 61700056 61774945 61774946 61774949 61782868 61792525 61815347 61815348 61828039 61850979 61858126 61890425 61897705 61921815 61934577 61934578 61951259 61951260 62002275 62002276 62031695 62037785 62037786 62037787 62146201 62171303 62171304 62213272 62219426 62227191 62253341 62253342 62253343 62253358 62253360 62054520 61774950 61774951 61798414 61798417 61798418 61803052 61803053 61828041 61850980 61850981 61873634 61873635 61890426 61897706 61906723 61906725 61951261 61951262 62017624 62017625 62017626 62031698 62095808 62171307 62197644 62197645 62213280 62219427 62240213 62240216 62240218 62240221 62240223 62240224 62318171 62318172 62318173 62318176 62318177 62318180 62318182 62318183 62318185 62318186 62318188 62318189 62318191 62318193 61644211 61666114 61686799 61700058 61774953 61774958 61798423 61803054 61803055 61828042 61850982 61858127 61873637 61897707 61934579 61951263 61964353 62008238 62017627 62090097 62090099 62090101 62146213 62197646 62197647 62227192 62227193 61780306 61977803 62054525 62106378 61951264 62090102 62157180 62093248 62171310 61927737 61969231 62031700 61969232 62137458 61815351 61878377 62141642 61815352 62046412 62165416

Where was it sold?

US Nationwide Distribution

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.

Other products in this recall event

70 other products · FDA event 72900

This product is part of a recall event; the main page for the event is Product 25 consists of all product under product recalled.

Reported	Class	Recall	Company	Reason	Where
23 Mar 2016	CLASS II	Product 25 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 48 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 12 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 31 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 29 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 52 consists of product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 18 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 5 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 28 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 51 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 36 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 17 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 45 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 34 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 59 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 10consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 65 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 14 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 62 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 19 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 35 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 67 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 54 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 1 consists of all product under , product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 64 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 37 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 27 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 7 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 8 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 3 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 15 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 56 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 42 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 43 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 4 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 16 consists of all product under poduct recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 46 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 69 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 30 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 60 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 63 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 70 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 66 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 20 consists of all prod oct under poduct recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 22 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 13 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 71 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 40 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 47 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 49 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 26 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 32 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 9 consists of all product under HRS, and same usage recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 50 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 39 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 57 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 11 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 33 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 38 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 58 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 55 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 6 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 2 consists of all products product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 61 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 68 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 21 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 23 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 44 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 24 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 72 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide

More recalls from Zimmer Manufacturing

All 90

Reported	Class	Recall	Company	Reason	Where
25 May 2016Device	CLASS II	Periarticular plating system, cancellous bone screw recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Mini MagnaFx Cannulated Screw Fixation System Small recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Herbert Cannulated Bone Screw System, Bone Screw Dia recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled	Zimmer Manufacturing	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide