Class II

Medical Device Recall: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Smith & Nephew, Inc. · November 24, 2025

Reason for Recall

Removal of affected lot of screws due to labeling error.

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.

States Affected

NATIONWIDE

Quantity Affected

168 units (US 83; OUS 85)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0957-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Smith & Nephew, Inc. Medical Device Recall: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. | SafeCheck