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

Product 32 consists of all product under product recalled

Zimmer Manufacturing is recalling Product 32 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.: 61849585 61912445 61912446 61849586 61849587 61912447 61912448 61941352 61827182 61849582 62024187 62153287 61774747 61827165 61827167 61849584 61904625 61928623 62024188 62024188N 61827172 61827173 61865263 61865265 61904627 61912468 62024189 62031681 62211067 62024189N 61827157 61870904 61904626 61928624 62024190 62145270 62160893 61811070 61827193 61870905 61944998 62024191 62031682 62145271 62153288 62180565 61827151 61840634 61928627 61928628 62031639 62145272 62160895 61870906 61900329 62031646 62180567 61789465 61811156 61840635 61895711 61895713 61895714 61912679 61912682 61912691 61912694 61912695 61912699 61644731 61785346 61855921 61906705 62161934 61660596 61799289 61865276 61906699 61960093 61960095 62017439 62072611 62129843 62180552 62180552N 61660597 61865277 61865278 61936609 61936613 61963653 61988334 62017440 62027372 62040734 62112691 62138496 62142211 62328120 61660601 61799283 61799285 61835773 61865279 61906706 61936621 61936623 61981198 61981199 61981201 62009804 62027373 62086218 62097341 62112695 62198887 62258967 62027374 62027374N 61799286 61835774 61887206 61906707 61978705 61978706 62008674 62065599 62086222 62112699 62187870 62328128 61988338 61612598 61660607 61788245 61843085 61865281 61906701 61968182 61968183 62008675 62086226 62097343 62187869 62198874 62258968 61988351 62180554 61819964 61880819 61968184 62017438 62086230 62138499 62223009 61914885 62069022 61612601 61887207 61968185 62053620 62112701 62198875 61955489 62027384 61968186 62040193 62161936 61887209 61946364 62005539 62129844 62198877 61685418 61988350 62085978 61865282 61988337 62027385 62097346 61923065 62065601 61887210 61978707 62005540 62072612 61946365 62072613 61887212 61960099 61963652 62072614 62198878 62204637 62097339 61887213 61978710 62053628 62161940 61799296 62005538 61923068 62053629 62138505 62204640 62304903 62304903N 62008676 61788253 62017441 61774750 61906704 61923071 62129845 62161957 62328136 61840636 62069021 62180559 61840639 62153285 61635183 61944996 62198879 61915566 62103709 62304798 61944997 62103708 62153286 62198882 61919343 62019689 62146161 61660577 61777801 61919344 62019685 62103711 62198883 62328137 61664837 61777802 61915567 62019692 62180561 62198885 61811065 61873034 62069020 62103713 62141641 62165346 62197616 62210960 61804519 61811078 61849807 61887195 61993279 62072604 62072605 62142180 62187532 62304821 62304821N 61804520 61811152 61851962 61882672 61897689 61980116 62006416 62040561 62072606 62072607 62110004 62134893 62187535 62211064 61635186 61640832 61707780 61825947 61825949 61851966 61851968 61882676 61934178 61934182 61952701 61990341 62033050 62052729 62052731 62110006 62187537 62197617 62211065 62326527 62326527N 61804524 61804525 61825952 61825953 61825954 61851971 61867102 61887198 61897690 61897691 61934184 61934186 61980117 61980118 61990343 62006417 62006418 62065595 62072608 62072609 62072610 62110007 62134896 62134897 62160888 62187547 62204641 62223014 62258984 61640834 61750821 61754464 61789464 61825955 61839816 61851974 61867103 61882674 61887201 61919346 61919348 61934188 61974386 61974387 61990346 61999821 61999822 62052727 62052728 62065593 62097845 62097846 62097848 62103726 62160889 62160890 62165347 62197618 62204643 62239553 62354446 61764291 61764337 61764338 61839817 61851977 61867104 61867105 61887203 61919355 61919357 61934191 61993280 61993281 61999823 61999824 62080380 62080383 62110008 62110009 62160891 62176427 62204645 62258985 62304868 62304868N 61616164 61777805 61825956 61851982 61867106 61887204 61934193 61952702 61952703 61999825 61999826 62080385 62080387 62080388 62080390 62142192 62176428 62187549 62211066 62271596 61777806 61804530 61825957 61851987 61867107 61952704 61952705 61990361 62006419 62065594 62095716 62103714 62144990 62176429 61777807 61789479 61789484 61825958 61839813 61839815 61851988 61867108 61867109 61867110 61919351 61919353 61952706 61952707 61980119 61980120 61980122 62006420 62006421 62065592 62085423 62085426 62085427 62085428 62110005 62142327 62142328 62187552 62223015

Quantity recalled4018

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-1130-2016
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: Heart & Vascular 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 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0MM 47115402200 HERBERT BONE SCREW, 3.0MM 47115402400 HERBERT BONE SCREW, 3.0MM 47115402600 HERBERT BONE SCREW, 3.0MM 47115402800 HERBERT BONE SCREW, 3.0MM 47115403000 HERBERT BONE SCREW, 3.0MM 47115502505 HERBERT CANNULATED BONE S 47115503005 HERBERT CANNULATED BONE S 47115503505 HERBERT CANNULATED BONE S 47115504005 HERBERT CANNULATED BONE S 47115504007 HERBERT CANNULATED BONE S 47115504505 HERBERT CANNULATED BONE S 47115504507 HERBERT CANNULATED BONE S 47115505005 HERBERT CANNULATED BONE S 47115505007 HERBERT CANNULATED BONE S 47115505505 HERBERT CANNULATED BONE S 47115505507 HERBERT CANNULATED BONE S 47115506005 HERBERT CANNULATED BONE S 47115506007 HERBERT CANNULATED BONE S 47115506505 HERBERT CANNULATED BONE S 47115506507 HERBERT CANNULATED BONE S 47115507005 HERBERT CANNULATED BONE S 47115507007 HERBERT CANNULATED BONE S 47115507505 HERBERT CANNULATED BONE S 47115507507 HERBERT CANNULATED BONE S 47115508005 HERBERT CANNULATED BONE S 47115508007 HERBERT CANNULATED BONE S 47115508505 HERBERT CANNULATED BONE S 47115508507 HERBERT CANNULATED BONE S 47115509005 HERBERT CANNULATED BONE S 47115509007 HERBERT CANNULATED BONE S 47115509505 HERBERT CANNULATED BONE S 47115509507 HERBERT CANNULATED BONE S 47115510005 HERBERT CANNULATED BONE S 47115510007 HERBERT CANNULATED BONE S 115001000 HERBERT MINI BONE SCREW 2 115001200 HERBERT MINI BONE SCREW 2 115001400 HERBERT MINI BONE SCREW 2 115001600 HERBERT MINI BONE SCREW 2 115001800 HERBERT MINI BONE SCREW 2 115002000 HERBERT MINI BONE SCREW 2 115002200 HERBERT MINI BONE SCREW 2 115002400 HERBERT MINI BONE SCREW 2 115201200 HERBERT/WHIPPLE CANN BONE 115201400 HERBERT/WHIPPLE CANN BONE 115201600 HERBERT/WHIPPLE CANN BONE 115201800 HERBERT/WHIPPLE CANN BONE 115202000 HERBERT/WHIPPLE CANN BONE 115202200 HERBERT/WHIPPLE CANN BONE 115202400 HERBERT/WHIPPLE CANN BONE 115202600 HERBERT/WHIPPLE CANN BONE 115202800 HERBERT/WHIPPLE CANN BONE 115203000 HERBERT/WHIPPLE CANN BONE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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.: 61849585 61912445 61912446 61849586 61849587 61912447 61912448 61941352 61827182 61849582 62024187 62153287 61774747 61827165 61827167 61849584 61904625 61928623 62024188 62024188N 61827172 61827173 61865263 61865265 61904627 61912468 62024189 62031681 62211067 62024189N 61827157 61870904 61904626 61928624 62024190 62145270 62160893 61811070 61827193 61870905 61944998 62024191 62031682 62145271 62153288 62180565 61827151 61840634 61928627 61928628 62031639 62145272 62160895 61870906 61900329 62031646 62180567 61789465 61811156 61840635 61895711 61895713 61895714 61912679 61912682 61912691 61912694 61912695 61912699 61644731 61785346 61855921 61906705 62161934 61660596 61799289 61865276 61906699 61960093 61960095 62017439 62072611 62129843 62180552 62180552N 61660597 61865277 61865278 61936609 61936613 61963653 61988334 62017440 62027372 62040734 62112691 62138496 62142211 62328120 61660601 61799283 61799285 61835773 61865279 61906706 61936621 61936623 61981198 61981199 61981201 62009804 62027373 62086218 62097341 62112695 62198887 62258967 62027374 62027374N 61799286 61835774 61887206 61906707 61978705 61978706 62008674 62065599 62086222 62112699 62187870 62328128 61988338 61612598 61660607 61788245 61843085 61865281 61906701 61968182 61968183 62008675 62086226 62097343 62187869 62198874 62258968 61988351 62180554 61819964 61880819 61968184 62017438 62086230 62138499 62223009 61914885 62069022 61612601 61887207 61968185 62053620 62112701 62198875 61955489 62027384 61968186 62040193 62161936 61887209 61946364 62005539 62129844 62198877 61685418 61988350 62085978 61865282 61988337 62027385 62097346 61923065 62065601 61887210 61978707 62005540 62072612 61946365 62072613 61887212 61960099 61963652 62072614 62198878 62204637 62097339 61887213 61978710 62053628 62161940 61799296 62005538 61923068 62053629 62138505 62204640 62304903 62304903N 62008676 61788253 62017441 61774750 61906704 61923071 62129845 62161957 62328136 61840636 62069021 62180559 61840639 62153285 61635183 61944996 62198879 61915566 62103709 62304798 61944997 62103708 62153286 62198882 61919343 62019689 62146161 61660577 61777801 61919344 62019685 62103711 62198883 62328137 61664837 61777802 61915567 62019692 62180561 62198885 61811065 61873034 62069020 62103713 62141641 62165346 62197616 62210960 61804519 61811078 61849807 61887195 61993279 62072604 62072605 62142180 62187532 62304821 62304821N 61804520 61811152 61851962 61882672 61897689 61980116 62006416 62040561 62072606 62072607 62110004 62134893 62187535 62211064 61635186 61640832 61707780 61825947 61825949 61851966 61851968 61882676 61934178 61934182 61952701 61990341 62033050 62052729 62052731 62110006 62187537 62197617 62211065 62326527 62326527N 61804524 61804525 61825952 61825953 61825954 61851971 61867102 61887198 61897690 61897691 61934184 61934186 61980117 61980118 61990343 62006417 62006418 62065595 62072608 62072609 62072610 62110007 62134896 62134897 62160888 62187547 62204641 62223014 62258984 61640834 61750821 61754464 61789464 61825955 61839816 61851974 61867103 61882674 61887201 61919346 61919348 61934188 61974386 61974387 61990346 61999821 61999822 62052727 62052728 62065593 62097845 62097846 62097848 62103726 62160889 62160890 62165347 62197618 62204643 62239553 62354446 61764291 61764337 61764338 61839817 61851977 61867104 61867105 61887203 61919355 61919357 61934191 61993280 61993281 61999823 61999824 62080380 62080383 62110008 62110009 62160891 62176427 62204645 62258985 62304868 62304868N 61616164 61777805 61825956 61851982 61867106 61887204 61934193 61952702 61952703 61999825 61999826 62080385 62080387 62080388 62080390 62142192 62176428 62187549 62211066 62271596 61777806 61804530 61825957 61851987 61867107 61952704 61952705 61990361 62006419 62065594 62095716 62103714 62144990 62176429 61777807 61789479 61789484 61825958 61839813 61839815 61851988 61867108 61867109 61867110 61919351 61919353 61952706 61952707 61980119 61980120 61980122 62006420 62006421 62065592 62085423 62085426 62085427 62085428 62110005 62142327 62142328 62187552 62223015

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 41 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 Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide