Device recall
Z-0098-2008: Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile…
FDA device recall · Class II · Encore Medical, Lp
Key facts
| Recall number (Z-number) | Z-0098-2008 |
|---|---|
| Recall event | 44788 |
| Product | Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. |
| Product code | KWY |
| Recalling firm | Encore Medical, Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 9, 2008 |
| 510(k) numbers | K953510 |
| FEI number | 1000116912 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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