BEUDAMED
    FDA Recall Terminated

    REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9") Polypropylene, Ultem, Radel, AL, SS. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

    Recall: Z-0867-2009 · Initiated August 6, 2008

    Recall

    Recall Number
    Z-0867-2009
    Event Number
    50516
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 6, 2008
    Posted
    January 29, 2009
    Terminated
    September 11, 2009
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9") Polypropylene, Ultem, Radel, AL, SS. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 18009 Jacksonville, Florida 32229-8009 USA 1-800-874-7711. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

    Reason

    Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.

    Action

    An IFU and correction letter will be issued to the field. Each distributor will receive instructions for delivering the correction letter to all customers. The customer letter will contain a reconciliation form to be returned once the customer receives the IFU for the twist drill. Contact Biomet Microfixation for additional information at 1-800-874-7711.

    Distribution

    Distributed domestically throughout the U.S. Distributed internationally to Argentina, Australia, Canada, Columbia, Hong Kong, Japan, Mexico, New Zealand, Puerto Rico, Taiwan, Thailand, Denmark, France, Netherlands, Greece, Italy, Norway, Finland, Spain, Czech Republic, and Venezuela.

    Quantity

    33