Device recall
Z-0349-2012: Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-0349-2012 |
|---|---|
| Recall event | 60245 |
| Product | Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013 |
| Product code | JWH |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 5, 2012 |
| 510(k) numbers | K970031 |
| FEI number | 1000116912 |
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