Recall Z-1955-2016 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Trabecular Metal Technology, Inc.
00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 A
| 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 |