BEUDAMED
    FDA Recall Terminated

    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor

    Recall: Z-0060-2012 · Initiated September 20, 2011

    Recall

    Recall Number
    Z-0060-2012
    Event Number
    59998
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    September 20, 2011
    Posted
    October 18, 2011
    Terminated
    July 17, 2012
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor

    Reason

    The product is labeled with an expiration date without adequate justification.

    Action

    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: [email protected]. For questions regarding this recall contact 901-867-4324.

    Distribution

    Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.

    Quantity

    596 units