Recall Z-1952-2016 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Trabecular Metal Technology, Inc.
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 - 00
| 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 |