FDA recall Z-1837-2020

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

Reason for recall

Restorations crack during the sintering process.

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-04-13

Report date

2020-05-13

Termination date

2021-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaan, N/A, Liechtenstein

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1837-2020