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Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Recalled December 24, 2025 · FDA recall Z-0957-2026 · Smith & Nephew
Hazard
Removal of affected lot of screws due to labeling error. · FDA Class II
Units
168 units (US 83; OUS 85)
Sold at
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.
Description
Removal of affected lot of screws due to labeling error.
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →