Device recall
Z-0367-2012: Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis…
FDA device recall · Class II · Zimmer Inc.
Key facts
| Recall number (Z-number) | Z-0367-2012 |
|---|---|
| Recall event | 60419 |
| Product | Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BUILD-UP TIVANIUM TI-6AL-4V ALLOY STERILE. Item number: 00-9991-021-55 |
| Product code | LPH |
| Recalling firm | Zimmer Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2013 |
| 510(k) numbers | K994286 |
| FEI number | 1000220733 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database