BEUDAMED
    FDA Recall Terminated

    ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.

    Recall: Z-1637-2010 · Initiated November 24, 2009

    Recall

    Recall Number
    Z-1637-2010
    Event Number
    55436
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 24, 2009
    Posted
    May 21, 2010
    Terminated
    October 21, 2010
    Address
    5677 Airline Rd, Arlington, TN, 38002

    Description

    ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.

    Reason

    The left medial pivot and right medial pivot inserts were co-mingled

    Action

    Wright Medical Technology, Inc. issued an "Urgent: Medical Device Voluntary Recall" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm. For further information, contact Wright Medical Technology, Inc. at 1-800-874-5630.

    Distribution

    Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.

    Quantity

    47 units