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U.S. Department of Health and Human Services

Class 2 Device Recall CONELOG Titanium Base

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 Class 2 Recall
CONELOG Titanium Base
see related information
Date Posted September 16, 2013
Recall Status1 Terminated on January 29, 2014
Recall Number Z-2206-2013
Recall Event ID 66143
Product Classification Abutment, Implant, Dental, Endosseous - Product Code NHA
Product 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.
Code Information lot 43377
Recalling Firm/
Manufacturer
Camlog Usa
5315 W 74th St Ste 200
Indianapolis, Indiana 46268-5136
Manufacturer Reason
for Recall
Product not cleared for sale/use in the United States.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
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.
Quantity in Commerce 3 in USA
Distribution USA Nationwide Distribution in the states of 4 US customers in NH. MD, CO, and IL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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