RecallRadar

FDA Device recall Z-1838-2020

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-st…

On 2020-05-13 the FDA classified a Class II recall of 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-st… by Ivoclar Vivadent Ag, citing restorations crack during the sintering process.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1838-2020
ClassificationClass II
Statusterminated
Initiated2020-04-13
Published2020-05-13
Last updated2026-09-13 11:55 UTC
CompanyIvoclar Vivadent Ag
DistributionUS

Product

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

Restorations crack during the sintering process.

Identifiers

code_infoLot Numbers: Y47472, Z000V0

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1838-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.