BEUDAMED
    FDA Enforcement Class II Terminated

    Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.

    Recall: Z-2396-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2396-2016
    Event ID
    74743
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 17, 2016
    Initiation Date
    July 1, 2016
    Classification Date
    August 11, 2016
    Termination Date
    June 8, 2017
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.

    Reason

    Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.

    Code Info

    Catalog No. 0930-9-003

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    241 units