Class 2 Device Recall Biosure HA

• Date Initiated by Firm: November 24, 2025
• Date Posted: December 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0957-2026
• Recall Event ID: 98051
• 510(K)Number: K080358 K142948
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
• Code Information: Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
• FEI Number: 1219602
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 130 & 120 Forbes Blvd; Mansfield MA 02048
• Manufacturer Reason for Recall: Removal of affected lot of screws due to labeling error.
• FDA Determined Cause: Packaging process control
• 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 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.
• Quantity in Commerce: 168 units (US 83; OUS 85)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HWC; 510(K)s with Product Code = HWC