Zirconium Oxide Dental Restoration Blocks Recalled for Potential Cracking
IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide dental blocks nationwide due to defective units that may crack during sintering and cause dental restoration fracture.
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: This is an FDA Class II recall without reported hospitalizations, injuries, or documented illnesses. The hazard is a risk of dental restoration fracture if undetected material cracks are present, but no actual patient incidents have been reported, meeting the criterion for High severity.
Plain-English summary
IVOCLAR VIVADENT AG is recalling 4080 units of IPS e.max ZirCAD CER/in. Prime B1 C17/5 zirconium oxide dental blocks with nationwide distribution. These blocks are used by dental professionals to fabricate fixed, full-contour restorations for anterior and posterior teeth.
Defective blocks may show cracks after the sintering process. If these cracks are not detected, the resulting dental restorations may fracture in the patient's mouth, potentially requiring restoration or replacement.
The affected batch numbers are Z065M0 and Z06CBH. Dentists and dental laboratories should discontinue use and contact IVOCLAR VIVADENT for further guidance on affected products.
The recalled product
- Product
- IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
- Manufacturer
- IVOCLAR VIVADENT AG
- Hazard
- fracture-risk
- material-defect
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)
- UDI-DI: (01)07615208438635 (11)231130 (10)Z065M0 (241)758441
- (01)07615208438635 (11)240112 (10)Z06CBH (241)758441 Batch No. Z065M0
- Z06CBH
Distribution
Distributed nationwide across the United States.
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