FDAFDA · Food and drugs·Recall number Z-2058-2015
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Published July 22, 2015 · Recall initiated: June 4, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- Domestic: None. International: Netherlands and Japan
- Lot
- Part number:856135060 Lot: 061300
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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