BEUDAMED
    FDA Recall Terminated

    PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.

    Recall: Z-0004-2008 · Initiated July 18, 2007

    Recall

    Recall Number
    Z-0004-2008
    Event Number
    38449
    Firm
    Abbott Spine
    FEI Number
    3000718496
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 18, 2007
    Posted
    October 2, 2007
    Terminated
    April 2, 2008
    Address
    12708 Riata Vista Cir, # B-100, Austin, TX, 78727-7167

    Description

    PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.

    Reason

    Tip of PathFinder surgical instrument broke during procedure.

    Action

    Firm notified sales representatives with an approved phone script on 7/18/2007.

    Distribution

    Nationwide.

    Quantity

    11 units