Ivoclar Vivadent, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0665-2018)

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 110/A1, Product code 541501AN, Catalog number 541501

Product Classification:

Class III

Date Initiated: August 3, 2017

Date Posted: February 28, 2018

Recall Number: Z-0665-2018

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: 2,153 units

Code Information:

Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021

Distribution Pattern:

US and Canada

Voluntary or Mandated:

Voluntary: Firm initiated