Summary
The FDA issued a Class II for Article No. NA6050411, Valiant PhD No. 1 Econo by Ivoclar Vivadent, Inc.. Reason: Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, .
Details
Source
Device Recall
External ID
Z-1006-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
Article No. NA6050411, Valiant PhD No. 1 Econo
Lot/Code Info: UDI-DI D707NA60504110, Lot Z066SD
Quantity Affected: 2 boxes (500 per box)
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
US Nationwide distribution in the states IN and TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
Amherst, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ivoclar Vivadent, Inc. has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ivoclar Vivadent, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ivoclar Vivadent, Inc. have FDA actions?
Ivoclar Vivadent, Inc. has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1006-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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