BEUDAMED
    FDA Recall 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 · Initiated April 15, 2013

    Recall

    Recall Number
    Z-1278-2013
    Event Number
    64913
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 15, 2013
    Posted
    May 9, 2013
    Terminated
    March 11, 2016
    Address
    325 Paramount Drive, Raynham, MA, 02767-5199

    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.

    Action

    DePuy Synthes sent an Urgent Voluntary Product Recall letter dated April 15, 2013, to all affected customers. The letter iidentified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check all inventories to locate and return the affected product. For returns customers were instructed call 1-877-379-4871 to obtain a goods authorization (RGA) number. Affected product should be returned to: Mitek Sports Medicine ATTN: Mitek Complaints 325 Paramouont Drive Rayham, MA 02067 For questions customers were instructed to call 1-877-379-4871.

    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