Z-0718-2017 Class II Terminated
FDA device recall Z-0718-2017 was initiated by Ivoclar Vivadent, Inc. on November 9, 2016 and is designated Class II. 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. The recall status is terminated (terminated June 18, 2018). Affected quantity: US: 1867 units, Canada: 465 units.
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: 1867 units, Canada: 465 units
Product Description
Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, 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: UL2221/July 28, 2017; TL4056/Nov 28, 2016