BEUDAMED
    FDA Recall Terminated

    SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level

    Recall: Z-2103-2013 · Initiated February 5, 2013

    Recall

    Recall Number
    Z-2103-2013
    Event Number
    65917
    Firm
    SpineNet
    FEI Number
    3006755626
    Product Code
    ODP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 5, 2013
    Posted
    August 27, 2013
    Terminated
    May 2, 2014
    Address
    1300 Minnesota Ave, Suite 200, Winter Park, FL, 32789-4800

    Description

    SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level

    Reason

    The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.

    Action

    SpineNET sent a Customer Notification letter dated 02/05/2013 to their only customer (Halifax Medical Center). The letter identified the affected product, problem and actions to be taken. Customers were informed to remove any copies of the original IFU-ACC-01 form from their records and replace with the IFU-ACC-02 form attached to the letter. For questions contact SpineNET office directly.

    Distribution

    USA Nationwide Distribution in the state of Florida

    Quantity

    400