BEUDAMED
    FDA Recall Terminated

    BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.

    Recall: Z-1365-2008 · Initiated February 6, 2008

    Recall

    Recall Number
    Z-1365-2008
    Event Number
    47341
    Firm
    Biomet 3i, Inc.
    FEI Number
    1038806
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2008
    Posted
    March 28, 2008
    Terminated
    July 7, 2008
    Address
    4555 Riverside Drive, Palm Beach Gardens, FL, 33410

    Description

    BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.

    Reason

    Seating Problems: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.

    Action

    USA customers were contacted by telephone with a follow-up fax. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.

    Distribution

    Worldwide

    Quantity

    270