Smith & Nephew, Inc. recalls BIOSURE HA SCREW

Removal of affected lot of screws due to labeling error.

An "Urgent Medical Device Recall Notice" dated 11/24/25 was sent to consignees via post and email. The notice instructs consignees to inspect their inventory and quarantine any devices identified in the notice. Consignees with product to return should complete the provided response form as instructed to facilitate return. Completed forms are to be sent to FieldActions@smith-nephew.com in order to obtain a Return Authorization. Consignees with no product to return are to return the provided form indicating as such. If a consignee is a sales representative, district office, or distributor they are to forward the provided notice to their customers. Questions can be directed to FieldActions@smith-nephew.com.

• FDA enforcement recordOfficial FDA database entry for Z-0957-2026
• FDA 510(k) clearance · K080358The device's official FDA premarket clearance record
• FDA 510(k) clearance · K142948The device's official FDA premarket clearance record
• FDA device classification · HWCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Smith & Nephew, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.