Ivoclar Vivadent, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0668-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

Product Classification:

Class III

Date Initiated: August 3, 2017

Date Posted: February 28, 2018

Recall Number: Z-0668-2018

Event ID: 79064

Reason for Recall:

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Status: Terminated

Product Quantity: 2 units

Code Information:

Batch: W12503, Exp. date: 01.04.2021

Distribution Pattern:

US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated