Recall Z-1953-2016 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Trabecular Metal Technology, Inc.
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
| 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 |