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.
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: 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
- Affected units
- 11,330
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.
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
Same manufacturer · IVOCLAR VIVADENT AG
See all →- HighZirconium Oxide Dental Restoration Blocks Recalled for Potential Cracking
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental blocks recalled due to cracking risk
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental blocks recalled for cracking risk
FDA (Devices) · 2024-05-08
- HighZirconium oxide dental restoration blocks may develop cracks during sintering
FDA (Devices) · 2024-05-08
- HighZirconium Oxide Dental Blocks Recalled Due to Fracture Risk
FDA (Devices) · 2024-05-08
Similar recalls
- HighIvoclar Vivadent recalls dental ceramic blocks due to cracking during sintering
FDA (Devices) · 2020-05-13
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
- HighDental amalgam powder may not triturate properly, affecting restoration strength
FDA (Devices) · 2024-02-14
- ModerateIvoclar Vivadent Recalls IPS Empress Universal Glaze Spray Due to Coarse Particles
FDA (Devices) · 2015-08-05
- ModerateIvoclar Vivadent Recalls Zenostar MT Color A4 Dental Porcelain Liquid
FDA (Devices) · 2016-10-12
- ModerateIvoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures
FDA (Devices) · 2016-12-14