Zirconium Oxide Dental Blocks Recalled Due to Fracture Risk
IVOCLAR VIVADENT AG is recalling 2,286 units of zirconium oxide blocks used for dental restorations because defective units may develop cracks during processing, potentially causing restorations to fracture in patients' mouths.
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 defective dental restoration blocks that may fracture in the patient's mouth. While no injuries have been reported, the product presents a risk of patient harm through potential fracture of dental restorations, meeting the criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
IVOCLAR VIVADENT AG manufactures IPS e.max ZirCAD CER/in. Prime BL1 C17/3, a zirconium oxide block used by dental professionals to fabricate fixed dental restorations (full-contour crowns and bridges) for anterior and posterior teeth.
A recall affecting 2,286 units of this product has been issued. The recalled material was distributed nationwide in the United States. The affected lot numbers are Z063MW and Z067JD.
The recall was initiated because the blocks may develop cracks during the sintering process. If these cracks are not detected before use, dental restorations fabricated from the affected blocks may fracture in the patient's mouth and require restoration.
Dental practitioners who have received these blocks should verify the lot numbers on their inventory and discontinue use of affected materials.
The recalled product
- Product
- IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
- Manufacturer
- IVOCLAR VIVADENT AG
- Hazard
- material-defect
- 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 (1)
- Z067JD
Distribution
Distributed nationwide across the United States.
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