BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
This recall is currently active, issued December 18, 2025. It was issued by Smith & Nephew, Inc..
- Company
- Smith & Nephew, Inc.
- Recall Initiated
- November 24, 2025
- Posted
- December 18, 2025
- Recall Number
- Z-0957-2026
- Quantity
- 168 units (US 83; OUS 85)
- Firm Location
- Mansfield, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
Root Cause
Packaging process control
Action Taken
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.