Device recall
Z-2674-2018: Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for…
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-2674-2018 |
|---|---|
| Recall event | 79315 |
| Product | Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. |
| Product code | KWI |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2023 |
| 510(k) numbers | K062898 |
| FEI number | 3003070421 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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