Device recall
Z-0308-2009: Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38…
FDA device recall · Class II · Stelkast Co
Key facts
| Recall number (Z-number) | Z-0308-2009 |
|---|---|
| Recall event | 49564 |
| Product | Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from… |
| Product code | JWH |
| Recalling firm | Stelkast Co |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2008 |
| 510(k) numbers | K980276 |
| 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