FDAHealthNovember 24, 2025
Smith & Nephew, Inc. — BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
⚠️ Removal of affected lot of screws due to labeling error.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 24, 2025
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.
What's affected?
- Product
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Brand
- Smith & Nephew, Inc.
- Lot code
- Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
Additional details
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 168 units (US 83; OUS 85).
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