BEUDAMED
    FDA Enforcement Class II Terminated

    Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

    Recall: Z-2778-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2778-2020
    Event ID
    85958
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Anjon Holdings
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 19, 2020
    Initiation Date
    June 18, 2020
    Classification Date
    August 10, 2020
    Termination Date
    November 25, 2020
    Address
    4801 Dawin Rd, N/A, Jacksonville, FL, 32207-9512, United States

    Description

    Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

    Reason

    High rate of galling of one threaded component.

    Code Info

    REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.

    Quantity

    249 devices