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

Tm Lps Tib Sz 3 C/d - 00588605310 Tm Lps Tib Sz 3 C/d recalled

Zimmer Trabecular Metal Technology is recalling Tm Lps Tib Sz 3 C/d - 00588605310 Tm Lps Tib Sz 3 C/d - 00588605312 Tm Lps Tib Sz 3 C/d, 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 codes00588605310 TM LPS TIB SZ 3 C/D, 10MM 61776840 61770817 61785352 61792636 61814243 61833815 61844337 61844340 61844341 00588605312 TM LPS TIB SZ 3 C/D, 12MM 61746696 61770813 61785354 61797196 61851748 00588605314 TM LPS TIB SZ 3 C/D, 14MM 61759785 61770812 61797197 00588605317 TM LPS TIB SZ 3 C/D, 17MM 61746694 61759789 61785353 00588605410 TM LPS TIB SZ 4 C/D, 10MM 61733406 61803955 61808992 61833823 61839387 61839369 00588605412 TM LPS TIB SZ 4 C/D, 12MM 61733410 61844343 00588605414 TM LPS TIB SZ 4 C/D, 14MM 61759795 61803956 00588605510 TM LPS TIB SZ 5 E/F, 10MM 61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226 00588605512 TM LPS TIB SZ 5 E/F, 12MM 61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227 00588605514 TM LPS TIB SZ 5 E/F, 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F, 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755 00588605612 TM LPS TIB SZ 6 E/F, 12MM 61759777 61769563 61770836 61785383 61792668 61809022 61844375 00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357 00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646 00588605510 TM LPS TIB SZ 5 E/F 10 MM 61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226 00588605512 TM LPS TIB SZ 5 E/F, 12MM 61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227 00588605514 TM LPS TIB SZ 5 E/F, 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F, 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755 00588605612 TM LPS TIB SZ 6 E/F, 12 mm 61759777 61769563 61770836 61785383 61792668 61809022 61844375 00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357 00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646

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-1952-2016
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 LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D, 14MM - 00588605414 TM LPS TIB SZ 5 E/F 10 MM - 00588605510 TM LPS TIB SZ 5 E/F, 12MM - 00588605512 TM LPS TIB SZ 5 E/F, 14MM - 00588605514 TM LPS TIB SZ 5 E/F, 17MM - 00588605517 TM LPS TIB SZ 6 E/F, 10MM - 00588605610 TM LPS TIB SZ 6 E/F, 12 mm - 00588605612 TM LPS TIB SZ 6 E/F, 17MM - 00588605617 TM LPS TIB SZ 7 G/H, 10MM - 00588605710 TM LPS TIB SZ 7 G/H, 12MM - 00588605712 TM LPS TIB SZ 7 G/H, 14MM - 00588605714 TM LPS TIB SZ 8 G/H, 10MM - 00588605810 TM LPS TIB SZ 8 G/H, 12MM - 00588605812 TM LPS TIB SZ 8 G/H, 14MM - 00588605814 TM LPS TIB SZ 8 G/H, 14MM - 00588605814 TM LPS TIB SZ 8 G/H, 17MM - 00588605817 TM LPS TIB SZ 3 E/F, 10MM - 00588606310 TM LPS TIB SZ 3 E/F, 12MM - 00588606312 TM LPS TIB SZ 3 E/F, 14MM - 00588606314 TM LPS TIB SZ 3 E/F, 17MM - 00588606317 TM LPS TIB SZ 4 E/F, 10MM - 00588606410 TM LPS TIB SZ 4 E/F, 12MM -00588606412 TM LPS TIB SZ 4 E/F, 14MM - 00588606414

Where it was distributed

Nationwide and Foreign.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

00588605310 TM LPS TIB SZ 3 C/D, 10MM 61776840 61770817 61785352 61792636 61814243 61833815 61844337 61844340 61844341 00588605312 TM LPS TIB SZ 3 C/D, 12MM 61746696 61770813 61785354 61797196 61851748 00588605314 TM LPS TIB SZ 3 C/D, 14MM 61759785 61770812 61797197 00588605317 TM LPS TIB SZ 3 C/D, 17MM 61746694 61759789 61785353 00588605410 TM LPS TIB SZ 4 C/D, 10MM 61733406 61803955 61808992 61833823 61839387 61839369 00588605412 TM LPS TIB SZ 4 C/D, 12MM 61733410 61844343 00588605414 TM LPS TIB SZ 4 C/D, 14MM 61759795 61803956 00588605510 TM LPS TIB SZ 5 E/F, 10MM 61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226 00588605512 TM LPS TIB SZ 5 E/F, 12MM 61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227 00588605514 TM LPS TIB SZ 5 E/F, 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F, 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755 00588605612 TM LPS TIB SZ 6 E/F, 12MM 61759777 61769563 61770836 61785383 61792668 61809022 61844375 00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357 00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646 00588605510 TM LPS TIB SZ 5 E/F 10 MM 61746720 61769557 61769558 61770832 61780784 61780785 61785367 61785368 61785373 61797210 61803932 61809010 61809011 61814248 61828080 61833827 61833828 61844353 61851754 61857226 00588605512 TM LPS TIB SZ 5 E/F, 12MM 61769560 61770830 61780783 61785371 61792657 61809008 61820712 61844345 61857227 00588605514 TM LPS TIB SZ 5 E/F, 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F, 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F, 10MM 61746706 61769562 61770835 61780792 61785382 61792667 61809028 61820717 61844374 61851755 00588605612 TM LPS TIB SZ 6 E/F, 12 mm 61759777 61769563 61770836 61785383 61792668 61809022 61844375 00588605617 TM LPS TIB SZ 6 E/F, 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H, 10MM 61739892 61746727 61769584 61776823 61770841 61785389 61792684 61814253 61814254 61828091 00588605712 TM LPS TIB SZ 7 G/H, 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H, 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H, 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H, 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H, 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H, 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F, 10MM 61759790 61776841 61770810 61785355 61797198 61814244 61839385 61844342 00588606312 TM LPS TIB SZ 3 E/F, 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F, 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F, 17MM 61785357 00588606410 TM LPS TIB SZ 4 E/F, 10MM 61733412 61752755 61769572 61776832 61770819 61770820 61792638 61792640 61792639 61803958 61803960 61803957 61828079 61828077 61833820 61833819 61839389 61839372 00588606412 TM LPS TIB SZ 4 E/F, 12MM 61752752 61769574 61776835 61792644 61808987 61844351 61857206 00588606414 TM LPS TIB SZ 4 E/F, 14MM 61733413 61769577 61792646

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

Reported	Class	Recall	Company	Reason	Where
22 Jun 2016	CLASS II	Tm Mono Tib Str Grn Sz 5 - 00588606510 Tm Mono Tib Str Grn 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	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide