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 | Packaging contained the incorrect size of femoral head from what was displayed on the label. |
| Product | smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4 |
| Quantity | 23 packages |
| Distribution | International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom. |
| Initiated | 2024-04-24 |
| Classified | 2024-05-24 |
| Recall number | Z-1901-2024 |
| 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-1901-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94555/
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