BEUDAMED
    FDA Enforcement Class II Terminated

    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.

    Recall: Z-1620-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1620-2013
    Event ID
    65301
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 10, 2013
    Initiation Date
    May 23, 2013
    Classification Date
    July 1, 2013
    Termination Date
    December 18, 2014
    Address
    345 E Main St, N/A, Warsaw, IN, 46580-2746, United States

    Description

    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.

    Reason

    This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.

    Code Info

    Item Number: 00-4305-019-40 with Lot Numbers 61588143 and 61612276. 2010 Market Withdrawal: Item #:430501940 Lot #'s: 60768814, 60806551, 60893241, 60946820, 60999665, 61031668, 61110808, 61170678, 61205673, 61244194, 61392456, 61430127

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.

    Quantity

    722 units (includes 2010 market withdrawal)