BEUDAMED
    FDA Recall Terminated

    Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002

    Recall: Z-1208-2009 · Initiated February 19, 2009

    Recall

    Recall Number
    Z-1208-2009
    Event Number
    51431
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 19, 2009
    Posted
    April 28, 2009
    Terminated
    February 3, 2010
    Address
    5677 Airline Rd, Arlington, TN, 38002

    Description

    Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002

    Reason

    The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.

    Action

    Wright Medical notified their distributors of the recall on 03/11/2009 by letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals and surgeons were notified of the recall also on 03/11/2009. All letters were delivered by Fed Ex.

    Distribution

    Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia.

    Quantity

    682 devices