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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/Diagnostic Equipment

Ivoclar Vivadent, Inc.: Valiant PhD No. 1 Econo Amalgam Recalled for Performance and Strength Defects

Agency Publication Date: February 7, 2024
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Summary

Ivoclar Vivadent, Inc. is recalling two boxes of Valiant PhD No. 1 Econo (Article No. NA6050411), which is a dental filling material. The recall was initiated because the amalgam powder may not mix correctly during the trituration process, which can negatively impact the material's physical properties such as its strength, compression, and working time. This defect means the dental restoration may not perform as expected for the patient. Consumers and dental professionals should check their inventory for Article No. NA6050411 with lot number Z066SD.

Risk

The affected dental amalgam may fail to bond or harden correctly due to improper mixing properties. This can lead to weakened dental fillings that lack the necessary compression strength, potentially resulting in premature failure of the dental restoration.

What You Should Do

  1. Identify if you have the affected product by checking the packaging for Article No. NA6050411, Product Name 'Valiant PhD No. 1 Econo', and Lot Number Z066SD.
  2. Verify the Unique Device Identifier (UDI-DI) on the box, which should match D707NA60504110.
  3. Immediately stop using any capsules from the affected lot for dental procedures.
  4. Contact your healthcare provider or Ivoclar Vivadent, Inc. for further instructions regarding the affected units and potential replacement or refund.
  5. For more information or to report concerns, contact the manufacturer, Ivoclar Vivadent, Inc., at their Amherst, New York location or call the FDA's consumer line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider Consultation

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

Affected Products

Product: Valiant PhD No. 1 Econo (500 capsules per box)
Model / REF:
Article No. NA6050411
UDI-DI D707NA60504110
Lot Numbers:
Z066SD

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93796
Status: Active
Manufacturer: Ivoclar Vivadent, Inc.
Sold By: Authorized distributors
Manufactured In: United States
Units Affected: 2 boxes (500 per box)
Distributed To: Indiana, Tennessee

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.