BEUDAMED
    FDA Enforcement Class II Ongoing

    REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

    Recall: Z-2107-2023 · Reported July 19, 2023

    Enforcement

    Recall Number
    Z-2107-2023
    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, 1.6mm x 4mm Profile Zero Auto-Drive Screw, 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 # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258

    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