Device recall
Z-0397-06: VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122…
FDA device recall · Class III · Plus Orthopedics USA
Key facts
| Recall number (Z-number) | Z-0397-06 |
|---|---|
| Recall event | 34255 |
| Product | VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument) |
| Product code | JWH |
| Recalling firm | Plus Orthopedics USA |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 29, 2007 |
| 510(k) numbers | K022204 |
| FEI number | 3001237832 |
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