Ivoclar Vivadent, Inc. recalls Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dent…
- Recall date
- November 9, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0717-2017
- FDA classification
- Class II
- Brand / firm
- Ivoclar Vivadent, Inc.
- Sold / distributed
- Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Why it was recalled
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
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