WRIGHT EVOLVE Proline Head — Class II medical device recall Z-1101-2020
Terminated recall by Wright Medical Technology, Inc., reported 2020-02-12. Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and la
| Recall number | Z-1101-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wright Medical Technology, Inc., Memphis, TN, United States |
| Recall initiated | 2019-12-27 |
| Classified | 2020-02-06 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-07-23 |
| Quantity | 39 devices |
| Reason classes | labeling |
| Lot numbers | 1633010 |
| Model numbers | 496H220 |
Product
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Reason for recall
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
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-1101-2020. 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.