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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 66143
Product Type Devices
Status Ongoing
Recalling Firm Camlog Usa
City Indianapolis
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Distribution in the states of NH, MD, CO, and IL.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
C2244.3808, CONELOG Titanium Base CC Ø3.8GH0.8 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. 43746 Class II Product not cleared for sale/use in the United States. 2 in USA Z-2203-2013
C2244.3820;, CONELOG Titanium Base CC Ø3.8GH2.0 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. 39437 Class II Product not cleared for sale/use in the United States. 1 in USA Z-2204-2013
C2244.4308 CONELOG Titanium Base CC Ø4.3GH2 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. 4460 and 44163 Class II Product not cleared for sale/use in the United States. 6 to US customers Z-2205-2013
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only Ø5.0GH 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. lot 43377 Class II Product not cleared for sale/use in the United States. 3 in USA Z-2206-2013
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