BEUDAMED
    FDA Recall Terminated

    TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO, Wright, Arlington, TN USA Used in the repair of tendons and ligaments

    Recall: Z-1524-2011 · Initiated January 11, 2011

    Recall

    Recall Number
    Z-1524-2011
    Event Number
    57854
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 11, 2011
    Posted
    March 4, 2011
    Terminated
    July 11, 2011
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO, Wright, Arlington, TN USA Used in the repair of tendons and ligaments

    Reason

    Driver may break during use.

    Action

    Wright Medical Technology Inc initiated their recall of the product by telephone to their distributors on January 11, 2011. The firm followed with letters sent on February 1, 2011, to distributors, hospital administrators, and surgeons. Distributors were asked to immediately complete the attached response form, confirming receipt of the notice, and return a copy to Wright Medical by fax to 901-867-4788. For questions they were instructed to call 800-874-5630. For questions regarding this recall call 901-867-4788.

    Distribution

    Nationwide Distribution including FL, NC, OH, IL, IN

    Quantity

    10 units