BEUDAMED
    FDA Enforcement Class II Terminated

    3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.

    Recall: Z-0921-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0921-2013
    Event ID
    64421
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genesys Orthopedic Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    February 20, 2013
    Classification Date
    March 8, 2013
    Termination Date
    September 9, 2013
    Address
    1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin, TX, 78746-6446, United States

    Description

    3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.

    Reason

    Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.

    Code Info

    Part Number: GCSF37512 and Lot Number: 0243

    Distribution

    USA Nationwide Distribution including the states of: CA and TX.

    Quantity

    9 cervical screws