Smith & Nephew, Inc. recalls BIOSURE HA SCREW
- Recalling company
- Smith & Nephew, Inc.
- Product
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Reason
- Removal of affected lot of screws due to labeling error.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 24, 2025
- Reported
- Dec 24, 2025
- 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.
- Status
- Ongoing
- Quantity
- 168 units (US 83; OUS 85)
- Lot / codes
- Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
- Company location
- Mansfield, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0957-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0957-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.