Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering
Ivoclar Vivadent AG is recalling 9 units of IPS e.max ZirCAD CER/inLab LT A1 C17/5 ceramic blocks because they 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 agency classified this as a Class II recall. The hazard involves a functional defect (cracking) in a medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ivoclar Vivadent AG is recalling 9 units of IPS e.max ZirCAD CER/inLab LT A1 C17/5 ceramic blocks, product number 686193. The affected units are identified by Lot Number Y48711. These products are intended for dental use in CAD/CAM technology.
The recall was initiated because the restorations crack during the sintering process. The agency has classified this recall as Class II. The products were distributed nationwide in the United States.
Dental professionals and consumers who possess these specific units should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 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: 686193
- Manufacturer
- Ivoclar Vivadent AG
- Affected units
- 9
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 (1)
- Lot Number: Y48711
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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