Z-1006-2024 Class II Ongoing
FDA device recall Z-1006-2024 was initiated by Ivoclar Vivadent, Inc. on December 21, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 2 boxes (500 per box).
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 boxes (500 per box)
Product Description
Article No. NA6050411, Valiant PhD No. 1 Econo
Reason for Recall
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 Pattern
US Nationwide distribution in the states IN and TN.
Code Information
UDI-DI D707NA60504110, Lot Z066SD