The Recall Desk
HighFDA (Devices)·Z-1840-2020·Announced 2020-05-13

Ivoclar Vivadent Recalls Dental Ceramic Blocks Due to Cracking During Sintering

Ivoclar Vivadent AG is recalling specific lots of IPS e.max ZirCAD CER/inLab Start.Kit LT dental ceramic blocks because they may crack during the sintering process.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (dental ceramic) where the defect (cracking) poses a safety risk, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Ivoclar Vivadent AG is recalling 6 units of IPS e.max ZirCAD CER/inLab Start.Kit LT, a ceramic product intended for dental use with CAD/CAM technology. The recall involves specific lot numbers: Z0007Z, Z000KK, Y49356, and Z006HV. The product was distributed nationwide in the United States.

The recall was initiated because the restorations may crack during the sintering process. This defect could affect the integrity of the dental work produced using these blocks.

Dental professionals and laboratories who purchased these specific lots should stop using the affected product. Consumers who have had dental work performed using these materials should contact their dentist to discuss the potential impact on their restorations.

The recalled product

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 zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot Numbers: Z0007Z
  • Z000KK
  • Y49356
  • Z006HV

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Ivoclar Vivadent AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →