BEUDAMED
    FDA Recall Terminated

    Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.

    Recall: Z-1221-2007 · Initiated August 3, 2007

    Recall

    Recall Number
    Z-1221-2007
    Event Number
    38983
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 3, 2007
    Posted
    September 18, 2007
    Terminated
    September 11, 2009
    Address
    4555 Riverside Drive, Biomet 3i, Palm Beach Gardens, FL, 33410-4200

    Description

    Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.

    Reason

    The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.

    Action

    International customers were contacted first by e-mail , then by fax letter 08/03/2007.

    Distribution

    Product was not distributed within the U.S. Product was distributed Internationally - Brazil, Argentina, Israel, Mexico, Colombia, Korea, Taiwan, Uruguay, Italy, Chile.

    Quantity

    240 (120 each model / lot)