Zirconium oxide dental restoration blocks may develop cracks during sintering
IVOCLAR VIVADENT recalls 12,525 zirconium oxide blocks for dental restorations after defective units may develop cracks during sintering, potentially causing restoration fractures.
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 of a dental material where defective blocks may crack during sintering, potentially causing restoration fracture in patients' mouths. Although no injuries have been reported and the hazard is theoretical, the potential for harm in a risk-of-harm product classifies this as High severity.
Plain-English summary
IVOCLAR VIVADENT AG is recalling IPS e.max ZirCAD CER/in. Prime A3 C17/5 zirconium oxide blocks (Article Number 758439) used in the fabrication of dental restorations. Approximately 12,525 units were distributed nationwide throughout the United States. The blocks are used by dental professionals to create fixed, full-contour restorations in anterior and posterior teeth.
Defective blocks may show cracks after sintering. If cracks are not detected before the material is used to fabricate a restoration, the finished restoration may fracture in the patient's mouth and require replacement.
Dentists using affected materials should inspect restorations for defects and verify batch numbers: Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, and Z06CBG. Patients concerned about their restorations should contact their dentist.
The recalled product
- Product
- IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
- Manufacturer
- IVOCLAR VIVADENT AG
- Hazard
- material-crack
- fracture-risk
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 (13)
- UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439
- (01)07615208438659 (11)231214 (10)Z067JF (241)758439
- (01)07615208438659 (11)231214 (10)Z067JC (241)758439
- (01)07615208438659 (11)231214 (10)Z067JG (241)758439
- (01)07615208438659 (11)231214 (10)Z067JB (241)758439
- (01)07615208438659 (11)240105 (10)Z06B6Z (241)758439
- (01)07615208438659 (11)240112 (10)Z06CBG (241)758439 Batch No. Z063MT
- Z067JF
- Z067JC
- Z067JG
- Z067JB
- Z06B6Z
- Z06CBG
Distribution
Distributed nationwide across the United States.
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