FDAClass IIDecember 14, 2016

Virtual XD recall

Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

Why was Virtual XD 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: UL2221/July 28, 2017; TL4056/Nov 28, 2016

Product
Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
US: 1867 units, Canada: 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