smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL… — Class II medical device recall Z-0281-2025
Ongoing recall by Smith & Nephew Inc, reported 2024-11-06, distributed in AL, CA, DE, GA, MS, NC, TN. Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of
| Recall number | Z-0281-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2024-10-02 |
| Classified | 2024-10-31 |
| Reported by FDA | 2024-11-06 |
| Distributed | AL, CA, DE, GA, MS, NC, TN |
| Countries outside the US | CA |
| Quantity | 5 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 03596010469212 |
| Lot numbers | 23LM02331 |
| Model numbers | 71421015 |
Product
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Reason for recall
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
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-0281-2025. 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.