Class II — Smith & Nephew Inc
| Recalling firm | Smith & Nephew, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic |
| Quantity | 8 units |
| Distribution | US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada |
| Initiated | 2024-10-02 |
| Classified | 2024-10-31 |
| Recall number | Z-0282-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Smith & Nephew Inc (Z-0282-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95494/
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