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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Dental EZ Group Star Dental Division: Titan Scaler Tips Recalled for Detachment and Injury Risk

Agency Publication Date: June 24, 2024
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Summary

Dental EZ Group Star Dental Division is recalling 224 units of Titan Scaler Perio tips and Titan Blis-Sonic Scalers. The tip holder portion of the assembly may be oversized, which prevents the scaler tip from staying securely seated during use. This defect could cause the tip to detach unexpectedly during a dental procedure, potentially leading to patient injury. These medical devices were distributed nationwide throughout the United States.

Risk

The scaler tip can become loose or fall out of its holder while in use because the attachment point was manufactured too large. This poses a direct risk of injury to patients if the sharp tip detaches during subgingival scaling or deep pocket dental work.

What You Should Do

  1. Check your inventory for Titan Scaler Tip - Perio (Catalog Number 261669) with UDI-DI D702261669, Lot Number 4881439, and date code stamp P424.
  2. Check for Titan Blis-Sonic Scaler packages containing the Perio tip (Part Numbers 264563 or 264565) with UDI-DI D7022645630 and Lot Numbers 4874201, 4904771, or 4964531.
  3. Immediately stop using any scaler tips or assemblies that match these specific lot numbers and date codes.
  4. Contact your healthcare provider or the manufacturer, Dental EZ Group Star Dental Division, for further instructions on returning the product and obtaining a replacement or refund.
  5. For more information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer contact for device correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Titan Scaler Tip - Perio
Model / REF:
261669
Lot Numbers:
4881439
Date Ranges: Date code stamp P424
Product: Titan Blis-Sonic Scaler packaged with Titan Scaler Tip - Perio
Model / REF:
264563
264565
Lot Numbers:
4874201
4904771
4964531

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94783
Status: Active
Manufacturer: Dental EZ Group Star Dental Division
Sold By: Authorized dental distributors
Manufactured In: United States
Units Affected: 2 products (32 units; 192 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.