Reported Dec 14, 2016 · Terminated
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental…
Ivoclar Vivadent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ivoclar Vivadent, Inc. · 175 Pineview Dr · Amherst, NY · 14228-2231
Is this the product you have?
Virtual XD Test Pack Heavy/Light Fast Set2 x 50 mlREF #/Product Code 646469
- Rx ONLY -- Product UsageDental impression material
- Lot codes and dates
2 of 2 products · 4 lot codes
Recalled lot codes, grouped by product number Date Lot codes and dates TL4095Jan 152017
TL4094Jan 152017
- Amount recalled
- US: 2090 units, Canada: 331 units, Australia: 465 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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