BEUDAMED
    FDA Recall Terminated

    Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery.

    Recall: Z-1377-2008 · Initiated February 19, 2008

    Recall

    Recall Number
    Z-1377-2008
    Event Number
    46938
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 19, 2008
    Posted
    August 19, 2008
    Terminated
    August 19, 2008
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Radius Rod Persuader is a non-sterile instrument for use with other devices in spinal surgery.

    Reason

    The t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail.

    Action

    Recall notification was sent via FedEx on February 19, 2008 to all branches/agencies. All questions are to be directed to Michelle Klein, Regulatory Compliance Specialist - 201-760-8256.

    Distribution

    Product was distributed to a limited population during a product launch for the purposes of gathering feedback on the product.

    Quantity

    65 units