BEUDAMED
    FDA Enforcement Class II Terminated

    UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.

    Recall: Z-2760-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2760-2015
    Event ID
    72000
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 23, 2015
    Initiation Date
    July 29, 2015
    Classification Date
    September 11, 2015
    Termination Date
    May 16, 2016
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.

    Reason

    MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.

    Code Info

    Model # MUCC1C LOT # 1186054

    Distribution

    Worldwide Distribution including Italy and Uruguay.

    Quantity

    61 pieces