Recall Z-1951-2016 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Trabecular Metal Technology, Inc.
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 -
| Date | Apr 15, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016. |
| Quantity | 19,884 total |
| Distribution | Nationwide and Foreign. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS Implex Corp., Aug 6, 2003 |