PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 13, 2020 Initiated: April 13, 2020 #Z-1838-2020

Product Description

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

Reason for Recall

Restorations crack during the sintering process.

Details

Recalling Firm
Ivoclar Vivadent AG
Units Affected
332
Distribution
US Nationwide distribution.
Location
Schaan, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Ivoclar Vivadent AG. Units affected: 332.
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-1838-2020.