Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cut...
FDA Device Recall #Z-1883-2018 — Class II — April 13, 2018
Recall Summary
| Recall Number | Z-1883-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 13, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Coltene Whaledent Inc |
| Location | Cuyahoga Falls, OH |
| Product Type | Devices |
| Quantity | 11 |
Product Description
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
Reason for Recall
The products are labeled with an incorrect product number.
Distribution Pattern
The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
Lot / Code Information
Batch I37640
Other Recalls from Coltene Whaledent Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1208-2023 | Class II | SciCan STATIS SL S10001 Dental Handpieces-Inten... | Jan 20, 2023 |
| Z-1494-2021 | Class II | Dental pins - TMS LINK PLUS Self-Threading Pins... | Mar 18, 2021 |
| Z-0464-2021 | Class II | Alpen Clinic 100 Carbide Instruments (R100057C) | Oct 20, 2020 |
| Z-0467-2021 | Class II | CEI Cutting Edge Instruments (PTC-57C) | Oct 20, 2020 |
| Z-0466-2021 | Class II | Clinic Pack 100 Pieces FG 57 100057C (100057C) | Oct 20, 2020 |
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.