CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report
Tm Cr Tib Sz 3 C-h- 00588604310 Tm Cr Tib Sz 3 C-h recalled
Zimmer Trabecular Metal Technology is recalling Tm Cr Tib Sz 3 C-h- 00588604310 Tm Cr Tib Sz 3 C-h - 00588604312 Tm Cr Tib Sz 3 C-h, distributed nationwide in the US. The recall was initiated on 15 Apr 2016 and the FDA has classified it as Class II.
Check your package
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-1951-2016
- 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 CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM - 00588604414 TM CR TIB SZ 4 C-H, 17MM - 00588604417, 00588604510 TM CR TIB SZ 5 C-H, 12MM - 00588604512 TM CR TIB SZ 5 C-H, 14MM - 00588604514 TM CR TIB SZ 5 C-H, 17MM - 00588604517, 00588604610 TM CR TIB SZ 6 C-H, 12MM 00588604612 TM CR TIB SZ 6 C-H, 14 MM 00588604614 TM CR TIB SZ 6 C-H, 17 MM 00588604617 TM CR TIB SZ 7 C-H, 10MM - 00588604710 TM CR TIB SZ 7 C-H, 12MM - 00588604712 TM CR TIB SZ 7 C-H, 14MM - 00588604714 TM CR TIB SZ 7 C-H, 17MM - 00588604717 TM CR TIB SZ 8 C-H, 10MM - 00588604810 TM CR TIB SZ 8 C-H, 12MM - 00588604812 TM CR TIB SZ 8 C-H, 14MM - 00588604814
Where it was distributed
Nationwide and Foreign.
Questions about this recall
Is Tm Cr Tib Sz 3 C-h- 00588604310 Tm Cr Tib Sz 3 C-h - 00588604312 Tm Cr Tib Sz 3 C-h recalled?
Yes. Zimmer Trabecular Metal Technology recalled Tm Cr Tib Sz 3 C-h- 00588604310 Tm Cr Tib Sz 3 C-h - 00588604312 Tm Cr Tib Sz 3 C-h on 15 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1951-2016.
Why was it recalled?
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.
Which lots are affected?
00588604310 TM CR TIB SZ 3 C-H, 10MM 61746701 61746701 61746702 61752725 61759780 61769546 61776838 61776839 61770816 61785348 61797187 61792632 61792633 61797183 61797182 61797181 61797184 61820708 61820710 61820709 61833813 61839384 61833812 61844335 61844336 00588604312 TM CR TIB SZ 3 C-H, 12MM 61746699 61759781 61776842 61770815 61785349 61797192 61797191 61808975 61833814 61851747 00588604314 TM CR TIB SZ 3 C-H, 14MM 61740710 61785350 61797194 61808984 00588604317 TM CR TIB SZ 3 C-H, 17MM 61746678 61759782 61785351 00588604410 TM CR TIB SZ 4 C-H, 10MM 61733408 61752758 61752759 61759791 61759792 61776830 61770821 61770822 61792647 61792649 61792648 61803945 61803944 61803946 61809003 61809004 61820711 61828074 61828075 61833817 61833818 61839368 61839376 61839390 61857205 61857207 00588604412 TM CR TIB SZ 4 C-H, 12MM 61759793 61776831 61770818 61792651 61803950 61803951 61803952 61809002 61828076 61833821 61833822 61844350 61857204 00588604414 TM CR TIB SZ 4 C-H, 14MM 61733409 61769569 61792653 61803953 61808998 61839386 61857217 00588604417 TM CR TIB SZ 4 C-H, 17MM 61759794 61792654 61803954 00588604510 61746703 61746726 61769547 61770833 61770824 61769548 61780780 61785361 61785362 61780778 61780779 61797201 61792658 61803927 61809014 61809013 61814245 61797202 61814246 61828082 61828083 61828084 61833824 61833825 61839378 61844352 61851749 61857222 61857228 00588604512 TM CR TIB SZ 5 C-H, 12MM 61746719 61769550 61770831 61769551 61785363 61780782 61792659 61797204 61814247 61828085 61833829 61833826 61839380 61851752 00588604514 TM CR TIB SZ 5 C-H, 14MM 61770827 61785364 61797205 61792660 61828081 61844344 61857223 00588604517 TM CR TIB SZ 5 C-H, 17MM 61746709 61770825 61785365 00588604612 TM CR TIB SZ 6 C-H, 12MM 61733401 61746705 61759774 61770838 61780791 61785379 61792665 61809052 61809053 61828087 61851757 00588604614 TM CR TIB SZ 6 C-H, 14MM 61746707 61733402 61759775 61792666 61828088 61851761 00588604617 TM CR TIB SZ 6 C-H, 17MM 61759776 61785378 61809046 00588604710 TM CR TIB SZ 7 C-H, 10MM 61746730 61739891 61746729 61776818 61776819 61770845 61770846 61792672 61797212 61809055 61814252 61828089 61833834 61833832 61851764 61851765 00588604712 TM CR TIB SZ 7 C-H, 12MM 61739889 61746728 61770844 61776821 61797217 61792675 61814251 61828090 61833833 61844354 61851762 00588604714 TM CR TIB SZ 7 C-H, 14MM 61785384 61792676 61809056 00588604717 TM CR TIB SZ 7 C-H, 17MM 61776822 61785385 61809057 00588604810 TM CR TIB SZ 8 C-H, 10MM 61733390 61776826 61792688 61803937 61844355 00588604812 TM CR TIB SZ 8 C-H, 12MM 61769567 61776827 61792689 00588604814 TM CR TIB SZ 8 C-H, 14MM 61733392
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zimmer Trabecular Metal Technology
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|---|---|---|---|---|---|
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| Device | CLASS III | The TM Ardis Interbody System implant is a convex recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | Porous Patella - 00587806532 Porous Patella recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | 00720504022 Acetab.cupw/sh,0deg,22mmx40mm recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
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