BEUDAMED
    FDA Recall Terminated

    LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,

    Recall: Z-0665-03 · Initiated January 28, 2003

    Recall

    Recall Number
    Z-0665-03
    Event Number
    25722
    Firm
    Implant Innovations, Inc.
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2003
    Posted
    March 20, 2003
    Terminated
    May 3, 2012
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410

    Description

    LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,

    Reason

    Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.

    Action

    The firm faxed a recall notification to their accounts on 1/28/2003. Consignees were requested to subrecall to the user/health professional level and respond. Also they were requested to provide disposition information.

    Distribution

    Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.

    Quantity

    68