The Recall Desk

FDA (Devices) recall action 75620

Ivoclar Vivadent, Inc. recalled 3 products on 2016-12-14

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-12-14
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • ModerateFDA (Devices)··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.

    Product
    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material

    Ivoclar Vivadent is recalling Virtual XD Refill Light Body Fast Set Wash Material because the dental impression material may fail to set up properly.

    Product
    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
    Category
    Distribution
    0 states