FDA Enforcement
Class II
Ongoing
Article No. NA6050411, Valiant PhD No. 1 Econo
Recall: Z-1006-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-1006-2024
- Event ID
- 93796
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ivoclar Vivadent, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- December 21, 2023
- Classification Date
- February 7, 2024
- Address
- 175 Pineview Dr, Amherst, NY, 14228-2231, United States
Description
Article No. NA6050411, Valiant PhD No. 1 Econo
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.
Code Info
UDI-DI D707NA60504110, Lot Z066SD
Distribution
US Nationwide distribution in the states IN and TN.
Quantity
2 boxes (500 per box)