stryker EVOLVE — Class II medical device recall Z-0006-2023
Ongoing recall by Wright Medical Technology, Inc., reported 2022-10-12, distributed nationwide. The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2
| Recall number | Z-0006-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wright Medical Technology, Inc., Memphis, TN, United States |
| Recall initiated | 2022-08-03 |
| Classified | 2022-10-04 |
| Reported by FDA | 2022-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 32 units |
| Reason classes | labeling |
| Lot numbers | 1704255 |
| Model numbers | 496S275 |
Product
stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, 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.
Reason for recall
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0006-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.