FDA-Device2023-07-19Class II
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Osteomed, LLC
Hazard
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.
Affected count
N/A
Manufactured in
3885 Arapaho Rd, N/A, Addison, TX, United States
Products
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2023Don't want to check this manually?
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