BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Recall
- Recall Number
- Z-0957-2026
- Event Number
- 98051
- Firm
- Smith & Nephew, Inc.
- FEI Number
- 1219602
- Product Code
- HWC
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- November 24, 2025
- Posted
- December 18, 2025
- Address
- 130 & 120 Forbes Blvd, Mansfield, MA, 02048
Description
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
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 [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].
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.
168 units (US 83; OUS 85)