BEUDAMED
    FDA Recall Terminated

    Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.

    Recall: Z-2335-2010 · Initiated January 12, 2009

    Recall

    Recall Number
    Z-2335-2010
    Event Number
    53811
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2009
    Posted
    August 31, 2010
    Terminated
    December 22, 2010
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.

    Reason

    The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.

    Action

    The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice. For questions or assistance, please contact Zimmer Spine at 800-326-0635.

    Distribution

    Worldwide.

    Quantity

    691