BEUDAMED
    FDA Recall Terminated

    Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410

    Recall: Z-0128-2008 · Initiated October 8, 2007

    Recall

    Recall Number
    Z-0128-2008
    Event Number
    45431
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 8, 2007
    Posted
    January 17, 2008
    Terminated
    July 10, 2008
    Address
    4555 Riverside Dr, Biomet 3i, Palm Beach Gardens, FL, 33410-4200

    Description

    Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410

    Reason

    Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.

    Action

    Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.

    Distribution

    Worldwide Distribution - USA, Italy, France, Spain and UK.

    Quantity

    114