Z-1837-2020 Class II Terminated
FDA device recall Z-1837-2020 was initiated by Ivoclar Vivadent AG on April 13, 2020 and is designated Class II. Reason for recall: Restorations crack during the sintering process. The recall status is terminated (terminated January 22, 2021). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 13, 2020
- Termination Date
- January 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
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
Reason for Recall
Restorations crack during the sintering process.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Number: Y48711