Zirconium oxide dental blocks recalled due to cracking and fracture risk
IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide blocks nationwide because they may develop cracks after sintering that could cause dental 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: FDA Class II medical device with theoretical risk of harm (dental restoration fracture). No injuries or illnesses reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
IVOCLAR VIVADENT AG is recalling 11,330 units of IPS e.max ZirCAD CER/in. Prime A2 C17/5 zirconium oxide blocks distributed nationwide in the United States. These blocks are used to fabricate fixed, full-contour restorations for anterior and posterior teeth.
The blocks may develop cracks during the sintering process. If these cracks go undetected, dental restorations made from the affected blocks may fracture in the patient's mouth, potentially requiring repair or replacement.
This recall affects dental professionals and patients nationwide who have received or may receive restorations fabricated from the recalled batches. Affected batch numbers include Z063MX, Z067JH, Z067J9, Z06B6Y, and Z06D4N.
Dental professionals should examine restorations created from the recalled material for signs of damage or cracking. Patients who experience a broken or fractured restoration should contact their dentist immediately. Healthcare providers and patients can report adverse events related to this product to the FDA.
The recalled product
- Product
- IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
- 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 (8)
- UDI-DI: (01)07615208438666 (11)231117 (10)Z063MX (241)758438
- (01)07615208438666 (11)231214 (10)Z067JH (241)758438
- (01)07615208438666 (11)240105 (10)Z06B6Y (241)758438
- (01)07615208438666 (11)240118 (10)Z06D4N (241)758438 Batch No. Z063MX
- Z067JH
- Z067J9
- Z06B6Y
- Z06D4N
Distribution
Distributed nationwide across the United States.
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