BEUDAMED
    FDA Enforcement Class II Terminated

    Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.

    Recall: Z-0316-2018 · Reported January 10, 2018

    Enforcement

    Recall Number
    Z-0316-2018
    Event ID
    77986
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amendia, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 10, 2018
    Initiation Date
    July 7, 2017
    Classification Date
    January 4, 2018
    Termination Date
    October 15, 2019
    Address
    1755 W Oak Pkwy, N/A, Marietta, GA, 30062-2260, United States

    Description

    Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.

    Reason

    Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.

    Code Info

    Model # 12-31-4012, Lot #133039

    Distribution

    Distributed to states of: AL, FL, GA, NY, TX, and VA.

    Quantity

    40 screws