Ivoclar Vivadent, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0719-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 9, 2016

Date Posted: December 14, 2016

Recall Number: Z-0719-2017

Event ID: 75620

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.

Status: Terminated

Product Quantity: US: 2090 units, Canada: 331 units, Australia: 465 units

Code Information:

Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of Canada and Australia

Voluntary or Mandated:

Voluntary: Firm initiated