Device recall
Z-0005-2023: stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s…
FDA device recall · Class II · Wright Medical Technology, Inc.
Key facts
| Recall number (Z-number) | Z-0005-2023 |
|---|---|
| Recall event | 90772 |
| Product | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD. |
| Product code | KWI |
| Recalling firm | Wright Medical Technology, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K060731, K991915 |
| FEI number | 3010667733 |
At a glance
- 1–9 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