BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.

    Recall: Z-2594-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2594-2014
    Event ID
    68915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 17, 2014
    Initiation Date
    June 25, 2014
    Classification Date
    September 5, 2014
    Termination Date
    September 23, 2014
    Address
    4555 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.

    Reason

    Identifiers on the label are correct but the label has the incorrect color coding.

    Code Info

    Model Number IEHA458, Lot number: 1167545.

    Distribution

    US Distribution to NH and TX.

    Quantity

    6 units