BEUDAMED
    FDA Enforcement Class II Terminated

    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.

    Recall: Z-0061-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0061-2015
    Event ID
    69052
    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
    August 27, 2014
    Classification Date
    October 9, 2014
    Termination Date
    November 17, 2015
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

    Description

    Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.

    Reason

    The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.

    Code Info

    Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157

    Distribution

    Worldwide Distribution: US (Nationwide) including states of: AR, CA, CO, CT, IL, MA, NC, OH, PA, TN, TX, UT, VA, WA, WI; and Internationally to: AUSTRALIA, CHILE, UK, INDIA, IRELAND, JAPAN, NEW ZEALAND, RUSSIA, SINGAPORE, and SAUDI ARABIA.

    Quantity

    65 units