smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL… — Class II medical device recall Z-2621-2023
Ongoing recall by Smith & Nephew Inc, reported 2023-09-27, distributed in CA, CT, NC, NE, NV, OH, TX. The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW P
| Recall number | Z-2621-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2023-08-31 |
| Classified | 2023-09-20 |
| Reported by FDA | 2023-09-27 |
| Distributed | CA, CT, NC, NE, NV, OH, TX |
| Quantity | 8 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00885556234006 |
| Lot numbers | 23EM09878 |
| Model numbers | 71421265 |
Product
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Reason for recall
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N 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-2621-2023. 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.