FDA Enforcement
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
Recall: Z-1839-2020
·
Reported May 13, 2020
Enforcement
- Recall Number
- Z-1839-2020
- Event ID
- 85450
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ivoclar Vivadent AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 13, 2020
- Initiation Date
- April 13, 2020
- Classification Date
- May 1, 2020
- Termination Date
- January 22, 2021
- Address
- Benderer Strasse 2, N/A, Schaan, N/A, N/A, Liechtenstein
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
Restorations crack during the sintering process.
Code Info
Lot Numbers: Y38637, Y47754, Y52136
Distribution
US Nationwide distribution.
Quantity
639 units