BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reported: December 24, 2025 Initiated: November 24, 2025 #Z-0957-2026
Product Description
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Reason for Recall
Removal of affected lot of screws due to labeling error.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units 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, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.. Recalled by Smith & Nephew, Inc.. Units affected: 168 units (US 83; OUS 85).
Why was this product recalled? ▼
Removal of affected lot of screws due to labeling error.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0957-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11