Z-1707-2024Class II

IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour...

Name: Z-1707-2024 IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour...
Creator: Ivoclar Vivadent Ag
Published: 2024-04-05
License: https://open.fda.gov/license/

Ivoclar Vivadent, Inc. / initiated 2024-04-05 / Open, Classified

FDA source

IVOCLAR VIVADENT AG began a recall of IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth... on 2024-04-05. FDA classified it as Class II and gives the reason as "Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1707-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-05
Posted: 2024-04-30
Recalling firm: Ivoclar Vivadent, Inc.
Product: IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
Product code: EIH Powder, Porcelain
Reason for recall: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
FDA root cause: Under Investigation by firm
Action: Ivokar issued Urgent Use and Safety Notice (03-2024-003-R) Letter to Distributors/End users via Fed'X or Email on 4/05/24. Letter states reason for recall, heath risk and action to take: 1. Identification of the IPS e.max ZirCAD Prime CEREC/inLab, C17 Block batches affected by the recall. 2. Separate the blocks so that they can no longer be used for the fabrication of dental restorations. 3. Contact the Customer Service of the distributor from whom you purchased the affected IPS e.max ZirCAD Prime CEREC/inLab, C17 Blocks to announce the return of the devices. Please note on the delivery bill Recall Ivoclar Vivadent AG (03-2024-003-R) . Your distributor will collect the devices affected by the recall and return them to Ivoclar. 4. In addition, please complete the Customer Reply Form in the attachment and send the completed form to [email protected]. 1. Queries regarding the Risk Minimising Safety Measures described in this Field Safety Notice should be addressed to: Responsible Department at Manufacturer of the Devices: Global Vigilance Email [email protected] Postal Address Ivoclar Vivadent AG Customer Care Global Vigilance Bendererstrasse 2 FL-9494 Schaan Liechtenstein All queries by email will be answered within one working day (24 hours). If you have given the products to a third party, please forward a copy of this information or inform Global Vigilance via [email protected]. 2. Queries regarding replacement for the IPS e.max ZirCAD Prime CEREC/inLab, C17 Block affected by this field safety notice please contact the customer service of your distributor of the Ivoclar Vivadent AG device. We will arrange all refunds with your responsible distributor. Your distributor will check the availability of the replacement material with Ivoclar Partner Support and let you know when the replacement material will be shipped to you.
Quantity in commerce: 4080 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: (01)07615208438635 (11)231130 (10)Z065M0 (241)758441; (01)07615208438635 (11)240112 (10)Z06CBH (241)758441 Batch No. Z065M0, Z06CBH

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1707-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1703-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1704-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1705-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1706-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1707-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1708-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30

Product code EIH

K051705Class IIIps E.max Cad/ips E.max ZircadIvoclar Vivadent, Inc. / cleared 2005-10-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)