IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations

FDA device recall Z-1705-2024 · posted 2024-04-30 · Open, Classified

Recall details

Recalling firm

IVOCLAR VIVADENT AG

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

Action taken

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 vigilance.li@ivoclar.com. 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 vigilance.li@ivoclar.com 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 vigilance.li@ivoclar.com. 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

EIH

Quantity affected

11330 units

Distribution

US Nationwide distribution.

Date initiated

2024-04-05

Date posted

2024-04-30

Location

LIECHTSTEIN, Germany

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