BEUDAMED
    FDA Recall Terminated

    Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)

    Recall: Z-0075-2011 · Initiated April 13, 2010

    Recall

    Recall Number
    Z-0075-2011
    Event Number
    54550
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 13, 2010
    Posted
    October 18, 2010
    Terminated
    February 10, 2012
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)

    Reason

    The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.

    Action

    Zimmer Spine issued an "Urgent Medical Device Correction" letter through the Zimmer Spine sales force to be provided to PathFinder system users in February 2010. the letter identified the affected product, safety issue, and actions to be taken by customers. Customers will receive replacement devices with a design change for the recalled devices, as they are available from the manufacturer.

    Distribution

    Worldwide Distribution: USA including states of AZ, CA, CO, FL, GA, LA, MI, MN, MO, NC, NH, NY, OH, OK, PA, TN, TX, WA, and WI, and the countries of Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland.

    Quantity

    1471 (888 subject to removal)