FDA-Device2017-02-22Class II
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Zimmer Biomet, Inc.
Hazard
The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
Sold states
Domestic: None VA/DOD: None Foreign: Japan
Affected count
11
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1220-2017Don't want to check this manually?
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