BEUDAMED
    FDA Recall Terminated

    Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.

    Recall: Z-2314-2009 · Initiated January 12, 2009

    Recall

    Recall Number
    Z-2314-2009
    Event Number
    52616
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    LZY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 12, 2009
    Posted
    September 24, 2009
    Terminated
    March 25, 2011
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.

    Reason

    46 mm Femoral head was mismarked and packaged as being 45 mm

    Action

    All affected Smith & Nephew Sales Representatives were notified of problem and sent recall notice in overnight mail on 01/12/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/12/2009. They were instructed to immediately quarantine the product for return. The firm re-issued the letter on 04/06/2009 to address hazard to health. Contact Smith & Nephew, Inc at 1.901.399.6771 if there are any questions.

    Distribution

    CA, FL, MI, and Canada

    Quantity

    10 units