Z-0719-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2016
- Initiation Date
- November 9, 2016
- Termination Date
- June 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 2090 units, Canada: 331 units, Australia: 465 units
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.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Code Information
Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017