BEUDAMED
    FDA Recall Terminated

    RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002 Intended use: Preparation of the Radius prior to device implantation

    Recall: Z-1779-2010 · Initiated April 8, 2010

    Recall

    Recall Number
    Z-1779-2010
    Event Number
    55637
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 8, 2010
    Posted
    June 7, 2010
    Terminated
    May 17, 2011
    Address
    5677 Airline Rd, Arlington, TN, 38002

    Description

    RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002 Intended use: Preparation of the Radius prior to device implantation

    Reason

    Drill guides from 2 lots may not seat properly on the compression block.

    Action

    The firm, Wright Medical Technology, Inc., sent an "URGENT: Medical Device Voluntary Recall Letter" on April 8, 2010 via FedEx to customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please examine their inventory of the products and check it against the information provided, and to immediately return any affected products to Wright as soon as possible. The customers were also instructed to contact Customer service at 800-238-7117 for return instructions and replacement inventory. In addition, the customers were to immediately complete and return by fax at 901-867-7401 the attached response confirming receipt of the notice. If you have any questions regarding this matter, please contact Debby Daurer at 800-874-5630.

    Distribution

    Worldwide: USA and The Netherlands

    Quantity

    13 units