Recall Z-0957-2026
Smith & Nephew, Inc. · initiated November 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Codes / lots: Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
Reason for recall
Removal of affected lot of screws due to labeling error.
FDA-determined 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.
Details
- Recall number
- Z-0957-2026
- Initiated
- November 24, 2025
- Posted by FDA
- December 18, 2025
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 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.
- Recalling firm
- Smith & Nephew, Inc., Mansfield, MA