BEUDAMED
    FDA Recall Terminated

    Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver.

    Recall: Z-1524-2009 · Initiated April 14, 2009

    Recall

    Recall Number
    Z-1524-2009
    Event Number
    52031
    Firm
    Ascension Orthopedics, Inc
    FEI Number
    3002788818
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    April 14, 2009
    Posted
    June 26, 2009
    Terminated
    September 24, 2010
    Address
    8700 Cameron Rd, Ste 100, Austin, TX, 78754

    Description

    Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver.

    Reason

    Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.

    Action

    Firm notified their distributors of recall via phone starting 04/14/09. Distributors replaced the recalled screwdrivers with ones that were manufactured to specification.

    Distribution

    Nationwide Distribution -- including states of CO, OR, and TX.

    Quantity

    9 units.