BEUDAMED
    FDA Enforcement Class II Terminated

    C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.

    Recall: Z-2206-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2206-2013
    Event ID
    66143
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Camlog Usa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 25, 2013
    Initiation Date
    August 28, 2013
    Classification Date
    September 16, 2013
    Termination Date
    January 29, 2014
    Address
    5315 W 74th St Ste 200, N/A, Indianapolis, IN, 46268-5136, United States

    Description

    C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.

    Reason

    Product not cleared for sale/use in the United States.

    Code Info

    lot 43377

    Distribution

    USA Distribution in the states of NH, MD, CO, and IL.

    Quantity

    3 in USA