PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 13, 2020 Initiated: April 13, 2020 #Z-1839-2020

Product Description

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

Reason for Recall

Restorations crack during the sintering process.

Details

Recalling Firm
Ivoclar Vivadent AG
Units Affected
639 units
Distribution
US Nationwide distribution.
Location
Schaan, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Ivoclar Vivadent AG. Units affected: 639 units.
Why was this product recalled?
Restorations crack during the sintering process.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1839-2020.