LEGION Posterior Stabilized OXINIUM Femoral Component — Class II medical device recall Z-1951-2021
Terminated recall by Smith & Nephew, Inc., reported 2021-06-30, distributed nationwide. The device components experienced a manufacturing process error that resulted in surface damage from product h
| Recall number | Z-1951-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2021-05-19 |
| Classified | 2021-06-24 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2023-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Lot numbers | 20HM17607 |
| Model numbers | 71421216 |
Product
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
Reason for recall
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
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-1951-2021. 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.