Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Reported: December 14, 2016 Initiated: November 9, 2016 #Z-0719-2017
Product Description
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
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.
Details
- Recalling Firm
- Ivoclar Vivadent, Inc.
- Units Affected
- US: 2090 units, Canada: 331 units, Australia: 465 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada and Australia
- Location
- Amherst, NY
Frequently Asked Questions
What product was recalled? ▼
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material. Recalled by Ivoclar Vivadent, Inc.. Units affected: US: 2090 units, Canada: 331 units, Australia: 465 units.
Why was this product recalled? ▼
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2016. Severity: Moderate. Recall number: Z-0719-2017.
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