BEUDAMED
    FDA Recall Terminated

    Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.

    Recall: Z-1981-2013 · Initiated July 16, 2013

    Recall

    Recall Number
    Z-1981-2013
    Event Number
    65833
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    JDG
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    July 16, 2013
    Posted
    August 17, 2013
    Terminated
    April 30, 2015
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.

    Reason

    Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which

    Action

    Zimmer is removing the devices from the field including distributor and hospital inventories. A notification was issued to known users of the product on 07/16/2013.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada, Mexico, Arab Emirates, Saudi Arabia, and Hong Kong.

    Quantity

    1,710 units are in distribution