BEUDAMED
    FDA Enforcement Class II Terminated

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563

    Recall: Z-1384-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1384-2020
    Event ID
    84771
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2020
    Initiation Date
    January 10, 2020
    Classification Date
    February 26, 2020
    Termination Date
    August 2, 2021
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563

    Reason

    Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment

    Code Info

    Lot Numbers: 1228593 1230791

    Distribution

    Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK

    Quantity

    N/A