FDAClass IIMay 13, 2020

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit recall

Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized…

Why was Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit recalled?

Restorations crack during the sintering process.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: Z0007Z, Z000KK, Y49356, Z006HV

Product
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized…
Recalling firm
Ivoclar Vivadent AG
Quantity
6 units
Distribution
US Nationwide distribution.
Recall date
May 13, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls