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Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Recalled July 19, 2023 · FDA recall Z-2107-2023 · Osteomed
Hazard
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. · FDA Class II
Units
N/A
Sold at
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.
Description
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Product
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Manufacturer(s)
Osteomed, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →