Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Recall date
- November 24, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0957-2026
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- 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.
Why it was recalled
Removal of affected lot of screws due to labeling error.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
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