Device recall
Z-2454-2015: Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage…
FDA device recall · Class II · Omnilife Science Inc.
Key facts
| Recall number (Z-number) | Z-2454-2015 |
|---|---|
| Recall event | 71470 |
| Product | Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems |
| Product code | FZX |
| Recalling firm | Omnilife Science Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2015 |
| FEI number | 3008342029 |
At a glance
- None Linked 510(k)s
- 1–9 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