CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report

Tm Mono Tib Str Grn Sz 5 - 00588606510 Tm Mono Tib Str Grn recalled

Zimmer Trabecular Metal Technology is recalling Tm Mono Tib Str Grn Sz 5 - 00588606510 Tm Mono Tib Str Grn Sz 5 - 00588606512 Tm Mono Tib, distributed nationwide in the US. The recall was initiated on 15 Apr 2016 and the FDA has classified it as Class II.

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Lot, batch or date codes00588606510 TM MONO TIB STR GRN SZ 5 10MM 61769554 61780786 61803934 00588606512 TM MONO TIB STR GRN SZ 5 12MM 61769555 61785358 00588606514 TM MONO TIB STR GRN SZ 5 14MM 61746710 61769556 61785359 61803935 00588606517 TM MONO TIB STR GRN SZ 5 17MM 61739874 61780787 61785360 61792655 61803936 61809005 00588606610 TM MONO TIB STR GRN SZ 6 10MM 61770839 61780793 61785374 61809020 61820718 61839382 00588606612 TM MONO TIB STR GRN SZ 6 12MM 61739882 61733397 61759778 61770840 61785375 61809018 61844376 00588606614 TM MONO TIB STR GRN SZ 6 14MM 61739885 61759779 61780795 61785376 61809015 00588606617 TM MONO TIB STR GRN SZ 6 17MM 61739883 61785377 61820719 00588606710 TM MONO TIB STR BLUE SZ 7 10MM 61769582 61792678 61797213 61851763 00588606712 TM MONO TIB STR BLUE SZ 7 12MM 61785386 61792681 61797214 61857235 00588606714 TM MONO TIB STR BLUE SZ 7 14MM 61780797 61785387 61809058 00588606717 TM MONO TIB STR BLUE SZ 7 17MM 61785388 61814249 00588607510 TM MONO TIB STR GRN SZ 5 10MM 61785366 61803928 61820713 61844346 00588607512 TM MONO TIB STR GRN SZ 5 12MM 61770823 61792661 61803929 61851753 00588607514 TM MONO TIB STR GRN SZ 5 14MM 61739865 61785369 61803931 00588607517 TM MONO TIB STR GRN SZ 5 17MM 61785370

Quantity recalled19,884 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-1953-2016
FDA event ID: 73536
Recalling firm: Zimmer Trabecular Metal Technology, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2016
FDA classified: 10 Jun 2016
Reported: 22 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

15 Apr 2016	Recall initiated by company
10 Jun 2016	Classified by FDA	+56 days
22 Jun 2016	Published in enforcement report	+12 days

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

Reason for recall

Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM MONO TIB STR GRN SZ 6 14MM - 00588606614 TM MONO TIB STR GRN SZ 6 17MM - 00588606617 TM MONO TIB STR BLUE SZ 7 10MM - 00588606710 TM MONO TIB STR BLUE SZ 7 12MM - 00588606712 TM MONO TIB STR BLUE SZ 7 14MM - 00588606714 TM MONO TIB STR BLUE SZ 7 17MM - 00588606717 TM MONO TIB STR GRN SZ 5 10MM - 00588607510 TM MONO TIB STR GRN SZ 5 12MM - 00588607512 TM MONO TIB STR GRN SZ 5 14MM - 00588607514 TM MONO TIB STR GRN SZ 5 17MM - 00588607517

Where it was distributed

Nationwide and Foreign.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

00588606510 TM MONO TIB STR GRN SZ 5 10MM 61769554 61780786 61803934 00588606512 TM MONO TIB STR GRN SZ 5 12MM 61769555 61785358 00588606514 TM MONO TIB STR GRN SZ 5 14MM 61746710 61769556 61785359 61803935 00588606517 TM MONO TIB STR GRN SZ 5 17MM 61739874 61780787 61785360 61792655 61803936 61809005 00588606610 TM MONO TIB STR GRN SZ 6 10MM 61770839 61780793 61785374 61809020 61820718 61839382 00588606612 TM MONO TIB STR GRN SZ 6 12MM 61739882 61733397 61759778 61770840 61785375 61809018 61844376 00588606614 TM MONO TIB STR GRN SZ 6 14MM 61739885 61759779 61780795 61785376 61809015 00588606617 TM MONO TIB STR GRN SZ 6 17MM 61739883 61785377 61820719 00588606710 TM MONO TIB STR BLUE SZ 7 10MM 61769582 61792678 61797213 61851763 00588606712 TM MONO TIB STR BLUE SZ 7 12MM 61785386 61792681 61797214 61857235 00588606714 TM MONO TIB STR BLUE SZ 7 14MM 61780797 61785387 61809058 00588606717 TM MONO TIB STR BLUE SZ 7 17MM 61785388 61814249 00588607510 TM MONO TIB STR GRN SZ 5 10MM 61785366 61803928 61820713 61844346 00588607512 TM MONO TIB STR GRN SZ 5 12MM 61770823 61792661 61803929 61851753 00588607514 TM MONO TIB STR GRN SZ 5 14MM 61739865 61785369 61803931 00588607517 TM MONO TIB STR GRN SZ 5 17MM 61785370

Where was it sold?

Nationwide and Foreign.

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

5 other products · FDA event 73536

This product is part of a recall event; the main page for the event is Tm Lps Tib Sz 3 C/d - 00588605310 Tm Lps Tib Sz 3 C/d recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jun 2016	CLASS II	Tm Lps Tib Sz 3 C/d - 00588605310 Tm Lps Tib Sz 3 C/d recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
22 Jun 2016	CLASS II	Tm Cr Tib Sz 3 C-h- 00588604310 Tm Cr Tib Sz 3 C-h recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
22 Jun 2016	CLASS II	Rev. Shell Liner 0d 00700504828 Rev. Shell Liner 10d recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
22 Jun 2016	CLASS II	00720504022 Acetab.cupw/sh,0deg,22mmx40mm recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
22 Jun 2016	CLASS II	Porous Patella - 00587806532 Porous Patella recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide

More recalls from Zimmer Trabecular Metal Technology

All 11

Reported	Class	Recall	Company	Reason	Where
20 Mar 2019Device	CLASS II	NexGenTrabecular Metal Tibial Half Block Augment recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
20 Mar 2019Device	CLASS II	NexGenTrabecular Metal Tibial Half Block Augment recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
10 May 2017Device	CLASS III	The TM Ardis Interbody System implant is a convex recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
22 Jun 2016Device	CLASS II	Porous Patella - 00587806532 Porous Patella recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide
22 Jun 2016Device	CLASS II	00720504022 Acetab.cupw/sh,0deg,22mmx40mm recalled	Zimmer Trabecular Metal Technology	Foreign Material	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide