BEUDAMED
    FDA Recall 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 · Initiated February 20, 2013

    Recall

    Recall Number
    Z-0921-2013
    Event Number
    64421
    Firm
    Genesys Orthopedic Systems, LLC
    FEI Number
    3008455034
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 20, 2013
    Posted
    March 8, 2013
    Terminated
    September 9, 2013
    Address
    1250 S Capital Of Texas Hwy, Bldg # 3 Suite 600, Austin, TX, 78746-6446

    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.

    Action

    Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.

    Distribution

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

    Quantity

    9 cervical screws