Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering
Ivoclar Vivadent AG is recalling 639 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves product failure (cracking) during the manufacturing process, which is a quality defect rather than a direct, reported health injury or high-risk pathogen exposure.
Plain-English summary
Ivoclar Vivadent AG is recalling 639 units of IPS e.max ZirCAD CER/inLab LT A3 C17/5 ceramic blocks for dental use. The affected product is intended for CAD/CAM technology and is identified by Product Number 686195.
The recall was initiated because the restorations crack during the sintering process. The specific lot numbers involved in this recall are Y38637, Y47754, and Y52136.
The product was distributed nationwide in the United States. Consumers and dental professionals should stop using the affected units and contact the recalling firm for further instructions.
The recalled product
- Product
- Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 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: 686195
- Manufacturer
- Ivoclar Vivadent AG
- Hazard
- Affected units
- 639
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 (3)
- Lot Numbers: Y38637
- Y47754
- Y52136
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.
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