smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE — Class II medical device recall Z-0363-2022
Terminated recall by Smith & Nephew, Inc., reported 2021-12-22, distributed nationwide. Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports we
| Recall number | Z-0363-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2021-11-01 |
| Classified | 2021-12-10 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2026-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 38 units |
| UPC / GTIN / UDI-DI | 00885556752999 |
| Lot numbers | 20HM10249, 20HM10250, 20HM10251, 20HM22783 |
| Model numbers | 72573101 |
Product
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Reason for recall
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
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-0363-2022. 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.