BEUDAMED
    FDA Recall Terminated

    3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.

    Recall: Z-2227-2009 · Initiated December 11, 2006

    Recall

    Recall Number
    Z-2227-2009
    Event Number
    52631
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    NDA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 11, 2006
    Posted
    September 22, 2009
    Terminated
    October 1, 2009
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410. Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration.

    Reason

    Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.

    Action

    Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product 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. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions.

    Distribution

    USA and Italy

    Quantity

    24