Z-2206-2013Class II
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 0.8 inkl HS
Camlog USA / initiated 2013-08-28 / Terminated
Camlog Usa began a recall of C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG... on . FDA classified it as Class II and gives the reason as "Product not cleared for sale/use in the United States". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2206-2013
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Camlog USA
- Product
- C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 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.
- Product code
- NHA Abutment, Implant, Dental, Endosseous
- Reason for recall
- Product not cleared for sale/use in the United States.
- FDA 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 in commerce
- 3 in USA
- Distribution
- USA Distribution in the states of NH, MD, CO, and IL.
- Product codes and lots
- lot 43377
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2203-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2204-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2205-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2206-2013 | Class II | Terminated | Voluntary: Firm initiated |
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