FDA-Device2023-07-19Class II
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, 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-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2023Don't want to check this manually?
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