BEUDAMED
    FDA Recall Terminated

    JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422264, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116

    Recall: Z-0953-2010 · Initiated January 23, 2009

    Recall

    Recall Number
    Z-0953-2010
    Event Number
    54269
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    HSX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 23, 2009
    Posted
    March 3, 2010
    Terminated
    March 25, 2011
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422264, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116

    Reason

    The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.

    Action

    All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 12/23/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. For questions, please contact the firm, Leah Easley at 901-399-6137.

    Distribution

    US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England

    Quantity

    578 units