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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 Device Recall CONELOG Titanium Base see related information
Date Initiated by Firm August 28, 2013
Date Posting Updated September 16, 2013
Recall Status1 Terminated 3 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/
Camlog Usa
5315 W 74th St Ste 200
Indianapolis IN 46268-5136
Manufacturer Reason
for Recall
Product not cleared for sale/use in the United States.
FDA Determined
Cause 2
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 Distribution in the states of NH, MD, CO, and IL.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.