FDAClass IIDecember 14, 2016

Virtual XD Test Pack Heavy/Light Fast Set recall

Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

Why was Virtual XD Test Pack Heavy/Light Fast Set recalled?

The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017

Product
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
US: 2090 units, Canada: 331 units, Australia: 465 units
Distribution
Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Recall date
December 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls