The Recall Desk

FDA (Devices) recall action 85450

Ivoclar Vivadent AG recalled 4 products on 2020-05-13

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-05-13
Critical
0
Units
986

Why these products were recalled

Restorations crack during the sintering process.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 639 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 9 units of IPS e.max ZirCAD CER/inLab LT A1 C17/5 ceramic blocks because they crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-13

    Ivoclar Vivadent Recalls Dental Ceramic Blocks Due to Cracking During Sintering

    Ivoclar Vivadent AG is recalling specific lots of IPS e.max ZirCAD CER/inLab Start.Kit LT dental ceramic blocks because they may crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 332 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process. The recall covers lots Y47472 and Z000V0 distributed nationwide.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
    Category
    Distribution
    0 states