FDA Device recall Z-0666-2018
Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
- FDA Device
- Class III
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class III recall of Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 by Ivoclar Vivadent, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0666-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-08-03 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ivoclar Vivadent |
| Distribution | n/a |
Product
Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Reason
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.
Identifiers
| code_info | Batch: V37176, Exp. date: 15.10.2020; Batch: V40818, Exp. date: 13.11.2020; Batch: V45145, Exp. date: 05.12.2020; Batch…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0666-2018%22
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