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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

Cosmedent, Inc.: FlexiCup Composite Finishing System Recalled for Crumbling Material

Agency Publication Date: November 2, 2023
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Summary

Cosmedent, Inc. is recalling approximately 7,400 packs of its FlexiCup Composite Finishing & Polishing System (Medium Blue, Six Pack) because the elastomer cup material can crumble during dental procedures. This recall affects the autoclavable aluminum oxide polishing instruments sold worldwide and nationwide in the United States. Consumers should identify if they have the affected blue polishing cups and contact their healthcare provider or the manufacturer immediately regarding the defect.

Risk

The elastomer cup material can crumble or break apart during use. This poses a risk of material fragments falling into a patient's mouth or being inhaled or swallowed during a dental finishing and polishing procedure.

What You Should Do

  1. Check your dental supply inventory for Cosmedent FlexiCup Composite Finishing & Polishing System, Medium (Blue), REF #403-101.
  2. Verify if your product matches any of the following affected lot numbers: 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, or 484781.
  3. You can also identify the product by checking for UDI-DI D77940310111 on the packaging.
  4. Contact your healthcare provider or Cosmedent, Inc. at 4646 N Ravenswood Ave, Chicago, IL for further instructions on returning the product and obtaining a potential refund.
  5. For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Guidance

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

Affected Products

Product: Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue)
Model / REF:
REF #403-101
UDI-DI D77940310111
Lot Numbers:
464948
465769
467512
470596
477493
478610
479776
482382
484262
484781

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92812
Status: Active
Manufacturer: Cosmedent, Inc.
Sold By: Direct sales; Dental distributors
Manufactured In: United States
Units Affected: 7,400 packs of 6
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.