Recall Z-0957-2026 ยท HWC Screw, Fixation, Bone
Smith & Nephew, Inc.
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
| Date | Dec 18, 2025 (initiated Nov 24, 2025) |
| Status | Open, Classified |
| Reason | Removal of affected lot of screws due to labeling error. |
| Root 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 a |
| 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. |
| FDA record | Open on fda.gov |