BEUDAMED
    FDA Enforcement Class II Terminated

    RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.

    Recall: Z-0038-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0038-2015
    Event ID
    69104
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 15, 2014
    Initiation Date
    September 3, 2014
    Classification Date
    October 7, 2014
    Termination Date
    November 9, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.

    Reason

    Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.

    Code Info

    J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and 592125.

    Distribution

    Worldwide Distribution -- USA, including the states of ME, MD, PA, MA, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, NC, VA, NY, TN, and IN; and, the countries of Canada, Australia, Austria, Belgium, Czech Republic, United Kingdom, France, Germany, Ireland, Israel, New Zealand, Norway, Poland, Slovenia, South Africa, Switzerland, and Chile.

    Quantity

    875 units