FDA Device recall Z-1951-2016
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, 17…
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of 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, 17… by Zimmer Trabecular Metal Technology, citing 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 pouch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1951-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Trabecular Metal Technology |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | 00588604310 TM CR TIB SZ 3 C-H, 10MM 61746701 61746701 61746702 61752725 61759780 61769546 61776838 61776839…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 618280 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1951-2016%22
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