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 | Terminated |
| Reason | The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US |
| Product | Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156 |
| Quantity | 2 units |
| Distribution | OH, TX, CO, TN, MI, PA, NJ |
| Initiated | 2018-05-11 |
| Classified | 2018-06-21 |
| Terminated | 2019-04-05 |
| Recall number | Z-2267-2018 |
| 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-2267-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80126/
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