Zimmer Biomet, Inc. recalls 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- Recall date
- January 10, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1220-2017
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Domestic: None VA/DOD: None Foreign: Japan
Why it was recalled
The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
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