BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
FDA device recall Z-0957-2026 · posted 2025-12-18 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- Removal of affected lot of screws due to labeling error.
- 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.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- HWC
- Quantity affected
- 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, I
- Date initiated
- 2025-11-24
- Date posted
- 2025-12-18
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSURE REGENESORB interference Screw (K142948) | Smith & Nephew, Inc. | 2015-01-13 |
| PLLA, HA SCREW (K080358) | Smith & Nephew Inc., Endoscopy Div. | 2008-04-23 |