BEUDAMED
    FDA Enforcement Class II Ongoing

    REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

    Recall: Z-2108-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2108-2023
    Event ID
    92479
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Osteomed, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2023
    Initiation Date
    May 31, 2023
    Classification Date
    July 7, 2023
    Address
    3885 Arapaho Rd, N/A, Addison, TX, 75001-4314, United States

    Description

    REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

    Reason

    Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

    Code Info

    Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006

    Distribution

    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.

    Quantity

    N/A