Biomet, Inc. recalls A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
- Recall date
- June 4, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2058-2015
- FDA classification
- Class II
- Brand / firm
- Biomet, Inc.
- Sold / distributed
- Domestic: None. International: Netherlands and Japan
Why it was recalled
Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
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