BEUDAMED
    FDA Recall Terminated

    C2244.3820;, CONELOG Titanium Base CC 3.8GH2.0 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-2204-2013 · Initiated August 28, 2013

    Recall

    Recall Number
    Z-2204-2013
    Event Number
    66143
    Firm
    Camlog Usa
    FEI Number
    3004433109
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    August 28, 2013
    Posted
    September 16, 2013
    Terminated
    January 29, 2014
    Address
    5315 W 74th St, Ste 200, Indianapolis, IN, 46268-5136

    Description

    C2244.3820;, CONELOG Titanium Base CC 3.8GH2.0 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.

    Action

    Camlog Usa notified four US consignees of the recall by telephone on August 5, 2013. The notification identified the recalled product, which did not have proper marketing clearance for distribution in the United States and asked customers to return all unused product. Cusotmers were sent an overnight UPS label via e-mail and asked customers to return the device to CAM:LOG USA Attn: Debby Callahan, 1822 Aston Avenue Carlsbad, CA 92007.

    Distribution

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

    Quantity

    1 in USA