EVOLVE STEM 8 — Class II medical device recall Z-2989-2020
Terminated recall by Wright Medical Technology Inc, reported 2020-09-30, distributed in CA, CO, FL, GA, MA, MO, OH, PA…. Lack of sterility assurance
| Recall number | Z-2989-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wright Medical Technology Inc, Arlington, TN, United States |
| Recall initiated | 2020-08-26 |
| Classified | 2020-09-21 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2021-04-27 |
| Distributed | CA, CO, FL, GA, MA, MO, OH, PA, TX |
| Countries outside the US | AU, CA, CL, ES, IL |
| Quantity | 16 stems |
| Reason classes | sterility |
| Lot numbers | 1668777 |
| Model numbers | 496S085 |
Product
EVOLVE STEM 8.5MM Model # 496S085
Reason for recall
Lack of sterility assurance
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-2989-2020. 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.