Recall Z-1046-2016 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
| Date | Feb 11, 2016 |
| Status | Terminated |
| Reason | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem. |
| Root cause | Under Investigation by firm |
| Action | Zimmer, Inc. initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. Electronic notices were e-mailed to distributors, and letters were mailed via certified mail on 02/11/2016 to distributors and hospitals. A field complaint investigation confirmed that this single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended Offset, and the device is an extended offset stem. Distributors will return on-hand product to Zimmer B |
| Quantity | 9 units |
| Distribution | Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032726 | ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES Zimmer, Inc., Oct 22, 2003 |