🔍 RecallPedia

Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

Class I - Dangerous
🏥 Medical Devices Recalled: November 9, 2016 Ivoclar Vivadent Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ivoclar Vivadent, Inc.
Reason for Recall:
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

Product Codes/Lot Numbers:

Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0719-2017

Related Recalls

Article No. NA6050411, Valiant PhD No. 1 Econo

Ivoclar Vivadent

Class I - Dangerous

Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

Dec 21, 2023 Other Medical Devices Nationwide View Details →