Device recall
Z-2466-2008: FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-2466-2008 |
|---|---|
| Recall event | 49116 |
| Product | FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the… |
| Product code | JWH |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2009 |
| 510(k) numbers | K923277, K941306, 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