Recall Z-1954-2016 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Trabecular Metal Technology, Inc.
REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X60 00701006028 REV. SHELL LINER 10D 28X62 00701006228 REV. SHELL LINE 10D 28X66 00701006628 REV. SHELL LINER 20D 28X48 00702004828
| 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 |