The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0718-2017·Announced 2016-12-14

Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures

Ivoclar Vivadent is recalling Virtual XD Refill Light Body dental impression material because it may fail to set properly as it ages.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect (failure to set) rather than a direct safety risk like injury or illness, fitting the criteria for moderate severity.

Plain-English summary

Ivoclar Vivadent, Inc. is recalling Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml (Product Code 646462). This dental impression material is distributed in the United States, Canada, and Australia.

The recall was initiated after the firm received complaints that the dental material failed to set up. The source text notes that as the dental material ages, the set time may increase.

Affected units include 1,867 units in the US and 465 units in Canada. The specific lots involved are UL2221 (expiration date July 28, 2017) and TL4056 (expiration date November 28, 2016). Consumers and healthcare providers should stop using the affected product and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
Manufacturer
Ivoclar Vivadent, Inc.
Category
Medical Device — Dental Materials
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot No./Expiration Date: UL2221/July 28
  • 2017
  • TL4056/Nov 28
  • 2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Ivoclar Vivadent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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