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 | Removal of affected lot of screws due to labeling error. |
| Product | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. |
| Quantity | 168 units (US 83; OUS 85) |
| Distribution | US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland. |
| Initiated | 2025-11-24 |
| Classified | 2025-12-18 |
| Recall number | Z-0957-2026 |
| 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-0957-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98051/
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