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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- Ivoclar Vivadent AG
- Hazard
- 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 →Related recalls
Same manufacturer · Ivoclar Vivadent AG
See all →- HighZirconium Oxide Dental Restoration Blocks Recalled for Potential Cracking
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental blocks recalled for cracking risk
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental restoration blocks may develop cracks during sintering
FDA (Devices) · 2024-05-08
- HighZirconium Oxide Dental Blocks Recalled Due to Fracture Risk
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental blocks recalled due to cracking and fracture risk
FDA (Devices) · 2024-05-08
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- HighZirconium oxide dental blocks recalled due to cracking and fracture risk
FDA (Devices) · 2024-05-08
- HighZirconium Oxide Dental Restoration Blocks Recalled for Potential Cracking
FDA (Devices) · 2024-05-08
- HighZirconium Oxide Dental Blocks Recalled Due to Fracture Risk
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental blocks recalled for cracking risk
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental blocks recalled due to cracking risk
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental restoration blocks may develop cracks during sintering
FDA (Devices) · 2024-05-08