FDA-Device2025-12-24Class II
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Smith & Nephew, Inc.
Hazard
Removal of affected lot of screws due to labeling error.
Sold states
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.
Affected count
168 units (US 83; OUS 85)
Manufactured in
130 & 120 Forbes Blvd, Mansfield, MA, United States
Products
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0957-2026Don't want to check this manually?
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