smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT — Class II medical device recall Z-0277-2025
Ongoing recall by Smith & Nephew Inc, reported 2024-11-06, distributed in TX. Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN
| Recall number | Z-0277-2025 |
|---|---|
| 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 | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | TX |
| Countries outside the US | ES, FR, GB |
| Quantity | 3 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 03596010543820 |
| Lot numbers | 23LM00479 |
| Model numbers | 71421163 |
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Reason for recall
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT 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-0277-2025. 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.