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.
This recall has been terminated (originally issued September 16, 2013).
- Company
- Camlog Usa
- Recall Initiated
- August 28, 2013
- Posted
- September 16, 2013
- Terminated
- January 29, 2014
- Recall Number
- Z-2204-2013
- Quantity
- 1 in USA
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Product not cleared for sale/use in the United States.
Distribution
USA Distribution in the states of NH, MD, CO, and IL.
Lot / Code Info
39437
Root Cause
No Marketing Application
Action Taken
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.
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C2244.3808, CONELOG Titanium Base CC 3.8GH0.8 inkl HS
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Endosseous dental implant abut...
Sep 16, 2013