Recall Z-2205-2013 ยท NHA Abutment, Implant, Dental, Endosseous
Camlog Usa
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.
| Date | Sep 16, 2013 (initiated Aug 28, 2013) |
| Status | Terminated |
| Reason | Product not cleared for sale/use in the United States. |
| Root 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 | 6 to US customers |
| Distribution | USA Distribution in the states of NH, MD, CO, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.