BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
FDA Recall Z-0957-2026 · Posted 2025-12-18
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Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeHWC
Date Initiated2025-11-24
Product Quantity168 units (US 83; OUS 85)
Reason for Recall
Removal of affected lot of screws due to labeling error.
Firm Action
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 [email protected] 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 [email protected].
Root Cause
Packaging process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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