A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Reported: July 22, 2015 Initiated: June 4, 2015 #Z-2058-2015
Product Description
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Reason for Recall
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 50 units
- Distribution
- Domestic: None. International: Netherlands and Japan
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw. Recalled by Biomet, Inc.. Units affected: 50 units.
Why was this product recalled? ▼
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2058-2015.
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