Z-0718-2017 Class II Terminated

Recalled by Ivoclar Vivadent, Inc. — Amherst, NY

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