BEUDAMED
    FDA Enforcement Class II Terminated

    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor

    Recall: Z-1267-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1267-2013
    Event ID
    64962
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Symmetry Medical/SSI
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2013
    Initiation Date
    April 10, 2013
    Classification Date
    May 7, 2013
    Termination Date
    May 12, 2014
    Address
    3034 Owen Dr, N/A, Antioch, TN, 37013-2413, United States

    Description

    Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor

    Reason

    There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

    Code Info

    244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, 296160

    Distribution

    Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK

    Quantity

    524 boxes of 10