Amherst, NY, United States
Ivoclar Vivadent, Inc. recalls
2 recalls recorded since 2018, most recently on 21 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 December 2023
- Reason
- Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
- Distribution
- US Nationwide distribution in the states IN and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1006-2024
- Article No. NA6050411, Valiant PhD No. 1 Econo
Terminated Class III Medical devices
- Recall started
- 3 August 2017
- Terminated
- 28 August 2018
- 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.
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0665-2018, Z-0666-2018, Z-0668-2018, Z-0667-2018
- Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
- Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
- Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
- Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.