Ivoclar Vivadent, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0667-2018)

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 210/A3, Product code 541503AN, Catalog number 541503

Product Classification:

Class III

Date Initiated: August 3, 2017

Date Posted: February 28, 2018

Recall Number: Z-0667-2018

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: 1,244 units

Code Information:

Batch: V37905, Exp. date: 21.10.2020; Batch: V45006, Exp. date: 04.12.2020; Batch: V49583, Exp. date: 12.01.2021; Batch: W04412, Exp. date: 20.02.2021; Batch: W13322, Exp. date: 07.04.2021

Distribution Pattern:

US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated