BEUDAMED
    FDA Recall Terminated

    LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

    Recall: Z-1819-2009 · Initiated January 22, 2009

    Recall

    Recall Number
    Z-1819-2009
    Event Number
    52582
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 22, 2009
    Posted
    August 23, 2009
    Terminated
    February 7, 2012
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

    Reason

    Products were mispackaged.

    Action

    All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.

    Distribution

    Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.

    Quantity

    16 units