Z-0666-2018 Class III Terminated

Recalled by Ivoclar Vivadent, Inc. — Amherst, NY

Recall Details

Product Type
Devices
Report Date
February 28, 2018
Initiation Date
August 3, 2017
Termination Date
August 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,255 units

Product Description

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

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.

Distribution Pattern

US and Canada

Code Information

Batch: V37176, Exp. date: 15.10.2020; Batch: V40818, Exp. date: 13.11.2020; Batch: V45145, Exp. date: 05.12.2020; Batch: V51367, Exp. date: 22.01.2021; Batch: W00520, Exp. date: 29.01.2021; Batch: W01514, Exp. date: 04.02.2021; Batch: W07036, Exp. date: 05.03.2021; Batch: W13323, Exp. date: 07.04.2021