# FDA recall Z-0666-2018

> **Ivoclar Vivadent, Inc.** · Class III · device recall initiated 2017-08-03.

## Product

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

US and Canada

## Key facts

- **Recall number:** Z-0666-2018
- **Recalling firm:** Ivoclar Vivadent, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-03
- **Report date:** 2018-02-28
- **Termination date:** 2018-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amherst, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2018

## Citation

> AI Analytics. FDA recall Z-0666-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0666-2018. Source: US FDA. Licensed CC0.

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