BEUDAMED
    FDA Recall Terminated

    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.

    Recall: Z-1895-2012 · Initiated May 12, 2012

    Recall

    Recall Number
    Z-1895-2012
    Event Number
    61952
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 12, 2012
    Posted
    June 27, 2012
    Terminated
    September 12, 2013
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.

    Reason

    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190.

    Action

    Zimmer sent URGENT DEVICE REMOVAL NOTIFICATION emails to distributors on May 12, 2012 to remove the product from all locations in their territories. This was an initial notification to prevent further distribution and use of the product. Zimmer Inc. sent follow-up notifications dated June 7, 2012 to the distributors, surgeons and hospital user accounts describing the product issue and providing recommended actions. Customers were directed to (877) 946-2761 for assistance or questions.

    Distribution

    Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.

    Quantity

    87 units