Class 2 Device Recall CONELOG Titanium Base

• Date Initiated by Firm: August 28, 2013
• Date Posted: September 16, 2013
• Recall Status: Terminated on January 29, 2014
• Recall Number: Z-2204-2013
• Recall Event ID: 66143
• Product Classification: Abutment, implant, dental, endosseous - Product Code NHA
• Product: 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.
• Code Information: 39437
• Recalling Firm/ Manufacturer: 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: 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: 1 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.