Zirconium oxide dental blocks recalled due to cracking risk
IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime zirconium oxide blocks because they may crack during sintering, potentially causing dental restorations to fracture in patients' mouths.
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: Class II medical device recall for a structural defect in a dental component that could cause patient harm if undetected. No illnesses or injuries have been reported. The risk-of-harm nature of the product with no reported injury meets the criterion for High severity.
Plain-English summary
IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime A1 C17/5 zirconium oxide blocks distributed nationwide. These blocks are used by dental professionals to fabricate fixed, full-contour restorations (such as crowns) for anterior and posterior teeth.
Defective blocks may develop cracks during the sintering process, which is the high-temperature heating used to harden the dental material. If these cracks are not detected before the restoration is placed in a patient's mouth, the restoration may fracture during use, requiring additional dental treatment.
Dental laboratories and dentists using the affected batch numbers (Z067J5, Z067J6, Z06CBD, Z06CBF) should stop using these blocks immediately. Any restorations already fabricated from these blocks should be inspected for visible defects before being delivered to patients.
Patients who have received restorations made from affected blocks should contact their dentist if they experience cracking, fracturing, or other problems with their restorations.
The recalled product
- Product
- IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
- Manufacturer
- IVOCLAR VIVADENT AG
- Hazard
- Affected units
- 7,445
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 (7)
- UDI-DI: (01)07615208438673 (11)231214 (10)Z067J5 (241)758437
- (01)07615208438673 (11)231214 (10)Z067J6 (241)758437
- (01)07615208438673 (11)240112 (10)Z06CBD (241)758437
- (01)07615208438673 (11)240112 (10)Z06CBF (241)758437 Batch No. Z067J5
- Z067J6
- Z06CBD
- Z06CBF
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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