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

Product 36 consists of all product under product recalled

Zimmer Manufacturing is recalling Product 36 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.: 61929352 61602065 61800233 61881344 61897089 61958884 61958885 61958886 61993617 62042512 62043576 62137020 62137021 62137022 62224312 61564745 61564747 61657666 61664936 61664937 61764346 61764347 61817406 61817407 61817408 61817409 61839143 61839144 61839145 61881305 61881306 61881307 61881322 61885590 61885592 61885593 61885594 61897083 61897084 61908110 61908114 61908115 61908116 61940081 61940086 61940088 61940090 61940092 61940093 61958887 61958888 61982446 61982447 62020899 62020900 62020901 62038717 62038721 62093613 62093615 62093617 62137023 62137024 62137025 62188625 62188626 62188627 61564754 61800242 61800243 61800244 61800245 61800251 61804379 61839148 61839149 61843698 61881323 61881328 61885595 61885596 61885598 61897085 61897086 61926555 61926556 61926558 61952708 61952709 61952710 61952711 61958889 61958890 61958891 61958892 61958893 61968087 61968088 61968090 62015514 62015520 62020902 62020903 62042513 62043577 62093623 62137026 62137028 62137029 62142069 62142072 62188628 62188629 62188638 62188640 62188643 61764348 61764349 61885603 61885605 61897087 61978180 61978181 61978182 61993618 62042514 62043578 62137030 62137032 61657688 61929353 61978183 61978184 62038740 62038741 62112767 62112769 61993622 62165490 61915262 61915263 61915264 62056670 62056673 62056674 62056675 62056676 62056677 62056678 62056679 62056680 62056681 62056682 62056683 62056684 62056685 62056686 62121124 62121125 62121126 62142063 62224315 62224317 62224320 62224321 62224322 62298604 61929356 61929357 62067205 62067217 62067222 62067225 62067228 62067229 62067241 62067242 62067244 62067245 62067246 62067253 62067255 62067257 62121153 62121154 62121155 62121156 62224328 62224329 62224330 62224331 62237601 62237605 62262081 62262081N 61993624 61915268 61915269 61915270 62130479 62130485 62130492 62130496 62130510 62130723 62130724 62130725 62130726 62137033 62137034 62237282 62237285 62237288 62237289 62237291 62237294 61993628 61915272 61915273 61915274 61915275 62129873 62129874 62129875 62129876 62129877 62129878 62129879 62129881 62137038 62165497 61915276 61915277

Quantity recalled268

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-1134-2016
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: Other Medical Devices

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 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5 225304045 INTERLOCKING IM SCREW 4.5 225304245 INTERLOCKING IM SCREW 4.5 225304545 INTERLOCKING IM SCREW 4.5 225305045 INTERLOCKING IM SCREW 4.5 225305245 INTERLOCKING IM SCREW 4.5 225305545 INTERLOCKING IM SCREW 4.5 225305745 INTERLOCKING IM SCREW 4.5 225306045 INTERLOCKING IM SCREW 4.5 225306545 INTERLOCKING IM SCREW 4.5 225307045 INTERLOCKING IM SCREW 4.5 Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

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.: 61929352 61602065 61800233 61881344 61897089 61958884 61958885 61958886 61993617 62042512 62043576 62137020 62137021 62137022 62224312 61564745 61564747 61657666 61664936 61664937 61764346 61764347 61817406 61817407 61817408 61817409 61839143 61839144 61839145 61881305 61881306 61881307 61881322 61885590 61885592 61885593 61885594 61897083 61897084 61908110 61908114 61908115 61908116 61940081 61940086 61940088 61940090 61940092 61940093 61958887 61958888 61982446 61982447 62020899 62020900 62020901 62038717 62038721 62093613 62093615 62093617 62137023 62137024 62137025 62188625 62188626 62188627 61564754 61800242 61800243 61800244 61800245 61800251 61804379 61839148 61839149 61843698 61881323 61881328 61885595 61885596 61885598 61897085 61897086 61926555 61926556 61926558 61952708 61952709 61952710 61952711 61958889 61958890 61958891 61958892 61958893 61968087 61968088 61968090 62015514 62015520 62020902 62020903 62042513 62043577 62093623 62137026 62137028 62137029 62142069 62142072 62188628 62188629 62188638 62188640 62188643 61764348 61764349 61885603 61885605 61897087 61978180 61978181 61978182 61993618 62042514 62043578 62137030 62137032 61657688 61929353 61978183 61978184 62038740 62038741 62112767 62112769 61993622 62165490 61915262 61915263 61915264 62056670 62056673 62056674 62056675 62056676 62056677 62056678 62056679 62056680 62056681 62056682 62056683 62056684 62056685 62056686 62121124 62121125 62121126 62142063 62224315 62224317 62224320 62224321 62224322 62298604 61929356 61929357 62067205 62067217 62067222 62067225 62067228 62067229 62067241 62067242 62067244 62067245 62067246 62067253 62067255 62067257 62121153 62121154 62121155 62121156 62224328 62224329 62224330 62224331 62237601 62237605 62262081 62262081N 61993624 61915268 61915269 61915270 62130479 62130485 62130492 62130496 62130510 62130723 62130724 62130725 62130726 62137033 62137034 62237282 62237285 62237288 62237289 62237291 62237294 61993628 61915272 61915273 61915274 61915275 62129873 62129874 62129875 62129876 62129877 62129878 62129879 62129881 62137038 62165497 61915276 61915277

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 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 41 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 Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide