Zirconium oxide dental blocks recalled for cracking risk
IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm product where defective dental blocks may cause fractures in patients' mouths. The FDA Class II classification and lack of any reported illnesses or injuries to date support a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
IVOCLAR VIVADENT AG is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime C2 C17/5 zirconium oxide blocks. These dental material blocks are used by dentists and dental laboratories to fabricate fixed dental restorations (crowns and bridges) for both front and back teeth. The product was distributed nationwide in the United States.
Defective blocks may develop cracks during the sintering process, which is the high-temperature firing that hardens the material. If these cracks are not detected before use, the resulting dental restorations may fracture in the patient's mouth, requiring additional restoration work.
The recalled product
- Product
- IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
- Manufacturer
- IVOCLAR VIVADENT AG
- Hazard
- Affected units
- 2,472
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
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