Device recall
Z-2375-2012: Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref…
FDA device recall · Class II · Omni Life Science
Key facts
| Recall number (Z-number) | Z-2375-2012 |
|---|---|
| Recall event | 62912 |
| Product | Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement. |
| Product code | JWH |
| Recalling firm | Omni Life Science |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2013 |
| 510(k) numbers | K094017 |
| FEI number | 3008342029 |
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