BEUDAMED
    FDA Recall Terminated

    GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA Drill guide used as manual surgical instrument during knee replacement surgeries.

    Recall: Z-1900-2010 · Initiated April 20, 2010

    Recall

    Recall Number
    Z-1900-2010
    Event Number
    55673
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 20, 2010
    Posted
    June 24, 2010
    Terminated
    December 7, 2011
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116

    Description

    GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA Drill guide used as manual surgical instrument during knee replacement surgeries.

    Reason

    Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side

    Action

    All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.

    Distribution

    International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.

    Quantity

    12 units