FDA Device recall Z-1046-2016
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 by Zimmer Biomet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1046-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-11 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | KY, MI, MO, NY, PA, SD, TN |
Product
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
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.
Identifiers
| code_info | Item: 00-7711-012-20, Lot: 62937093 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1046-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.