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Terminated

C2244.4308 CONELOG Titanium Base CC 4.3GH2 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.

FDA Recall Z-2205-2013 · Posted 2013-09-16

Recalling FirmCamlog Usa
Recall StatusTerminated
Product CodeNHA
Date Initiated2013-08-28
Date Terminated2014-01-29
Product Quantity6 to US customers

Reason for Recall

Product not cleared for sale/use in the United States.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

USA Distribution in the states of NH, MD, CO, and IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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