Device recall
Z-2136-2013: SC2316, Distal Femoral Augment with Screw Total knee replacement due to…
FDA device recall · Class II · Stelkast Co
Key facts
| Recall number (Z-number) | Z-2136-2013 |
|---|---|
| Recall event | 65823 |
| Product | SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions. |
| Product code | JWH |
| Recalling firm | Stelkast Co |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2014 |
| 510(k) numbers | K021908 |
| 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