Device recall
Z-1117-2018: Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex…
FDA device recall · Class II · OMNIlife science Inc.
Key facts
| Recall number (Z-number) | Z-1117-2018 |
|---|---|
| Recall event | 79268 |
| Product | Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following… |
| Product code | JWH |
| Recalling firm | OMNIlife science Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2019 |
| 510(k) numbers | K060192 |
| 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