BEUDAMED
    FDA Enforcement Class II Terminated

    DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.

    Recall: Z-1278-2013 · Reported May 15, 2013

    Enforcement

    Recall Number
    Z-1278-2013
    Event ID
    64913
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2013
    Initiation Date
    April 15, 2013
    Classification Date
    May 9, 2013
    Termination Date
    March 11, 2016
    Address
    325 Paramount Drive, N/A, Raynham, MA, 02767-5199, United States

    Description

    DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.

    Reason

    Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.

    Code Info

    Lot number:13A01

    Distribution

    Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.

    Quantity

    27 units