BEUDAMED
    FDA Recall Terminated

    Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243

    Recall: Z-0801-2007 · Initiated April 18, 2007

    Recall

    Recall Number
    Z-0801-2007
    Event Number
    37893
    Firm
    BioHorizons Implant Systems Inc One Perimeter Park South
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 18, 2007
    Posted
    May 11, 2007
    Terminated
    August 11, 2007
    Address
    Suite 230, South Birmingham, AL, 35243

    Description

    Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243

    Reason

    Dental implant system is missing ball attachment system.

    Action

    Letters explaining the problem and MBAS systems were sent via United Parcel Service (UPS) 3rd day package delivery to the consignees (both domestic and abroad) on 04/18/2007.

    Distribution

    Worldwide distribution ---- USA and country of Italy

    Quantity

    34 units