Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering
Ivoclar Vivadent AG is recalling 332 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process. The recall covers lots Y47472 and Z000V0 distributed nationwide.
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 structural defect (cracking) in a medical device that poses a risk of harm to patients if the defective restorations are used, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ivoclar Vivadent AG is recalling 332 units of IPS e.max ZirCAD CER/inLab LT A2 C17/5 ceramic blocks for dental use. The product is intended for CAD/CAM technology and is identified by Product Number 686194. The specific lots affected are Y47472 and Z000V0.
The recall was initiated because the restorations crack during the sintering process. This defect affects the structural integrity of the dental ceramic material during the manufacturing or processing stage.
The affected units were distributed nationwide in the United States. Dental professionals and laboratories using these specific lots should stop using the product and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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
- Manufacturer
- Ivoclar Vivadent AG
- Affected units
- 332
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 (2)
- Lot Numbers: Y47472
- Z000V0
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
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