Events

Recall of Device Recall CONELOG Titanium Base

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Camlog Usa.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66143
  • Event Risk Class
    Class 2
  • Event Number
    Z-2203-2013
  • Event Initiated Date
    2013-08-28
  • Event Date Posted
    2013-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121551
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Abutment, implant, dental, endosseous - Product Code NHA
  • 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.

Device

Device Recall CONELOG Titanium Base
  • Model / Serial
    43746
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Distribution in the states of NH, MD, CO, and IL.
  • Product Description
    C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 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.
  • Manufacturer
    Camlog Usa

Manufacturer

Camlog Usa
  • Manufacturer Address
    Camlog Usa, 5315 W 74th St Ste 200, Indianapolis IN 46268-5136
  • Manufacturer Parent Company (2017)
    Camlog Usa Inc
  • Source
    USFDA