Device recall
Z-0371-2010: Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint…
FDA device recall · Class II · Stelkast Co
Key facts
| Recall number (Z-number) | Z-0371-2010 |
|---|---|
| Recall event | 53772 |
| Product | Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental… |
| Product code | HSX |
| Recalling firm | Stelkast Co |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2009 |
| 510(k) numbers | K032824 |
| FEI number | 3004142400 |
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