BEUDAMED
    FDA Enforcement Class II Terminated

    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

    Recall: Z-1386-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1386-2018
    Event ID
    79653
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Southern Implants, (Pty.) Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 25, 2018
    Initiation Date
    March 8, 2018
    Classification Date
    April 16, 2018
    Termination Date
    September 26, 2019
    Address
    One Albert Road, Irene, Gauteng, N/A, South Africa

    Description

    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.

    Reason

    The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.

    Code Info

    Lot code: 251J00d2

    Distribution

    US, South Africa, France

    Quantity

    49 units