Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform ...
FDA Device Recall #Z-2078-2014 — Class II — June 13, 2014
Recall Summary
| Recall Number | Z-2078-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 13, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Dental EZ Group Star Dental Division |
| Location | Lancaster, PA |
| Product Type | Devices |
| Quantity | 45 |
Product Description
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
Reason for Recall
The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
Distribution Pattern
US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
Lot / Code Information
Lot # 2239818, Model - Titan-T 5K Motor, Catalog Number - 263940, with serial numbers: AC00001M7, AC00002M7, AC00003M7, AC00004M7, AC00005M7, AC00006M7, AC00007M7, AC00008M7, AC00009M7, AC00010M7, AC00011M7, AC00012M7 , AC00013M7, AC00014M7, AC00015M7, AC00016M7, AC00017M7, AC00018M7, AC00019M7, AC00020M7, AC00021M7, AC00022M7, AC00023M7, AC00024M7, AC00025M7 The recall was expanded in September 2014 to include additional lot #2251181 (catalog #263940) with serial numbers: AC00026M7, AC00027M7, AC00028M7, AC00029M7 , AC00030M7, AC00031M7, AC00032M7, AC00033M7, AC00034M7, AC00035M7 , AC00036M7, AC00037M7, AC00038M7, AC00039M7, AC00040M7, AC00041M7 , AC00042M7, AC00043M7, AC00044M7, AC00045M7.
Other Recalls from Dental EZ Group Star Dental Division
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2177-2024 | Class II | Titan Scaler Tip - Perio Model/Catalog Number:... | May 30, 2024 |
| Z-2178-2024 | Class II | Titan Blis-Sonic Scaler packaged with the Titan... | May 30, 2024 |
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.