Z-0717-2017 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: 4659 units, Canada: 729 units
Product Description
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, 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: UL2395/June 28, 2018; UL2293/Dec 31, 2017; UL2222/Aug 28, 2017; UL2220/July 28, 2017; TL4121/ Mar 28, 2017