C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: Endosseous dental impl...

FDA Device Recall #Z-2204-2013 — Class II — August 28, 2013

Recall Summary

Recall Number Z-2204-2013
Classification Class II — Moderate risk
Date Initiated August 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Camlog Usa
Location Indianapolis, IN
Product Type Devices
Quantity 1 in USA

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Lot / Code Information

39437

Other Recalls from Camlog Usa

Recall # Classification Product Date
Z-2205-2013 Class II C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8... Aug 28, 2013
Z-2206-2013 Class II C2244.5008 CONELOG Titanbasis CAD/CAM Conelog ... Aug 28, 2013
Z-2203-2013 Class II C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 ... Aug 28, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.