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IPS e.max ZirCAD recallZ-1703-2024 · Ivoclar Vivadent AG · initiated Apr 5, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ivoclar Vivadent AG or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1703-2024
Status
Open, Classified
Initiated by the company
Apr 5, 2024
Posted by the FDA
Apr 30, 2024
Recalling firm
Ivoclar Vivadent AG
Quantity
2286 units
Product code
EIH
FDA submissions
K051705
Distribution
US Nationwide distribution.

Product description

IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434

Code information (models, lots, serial numbers)

UDI-DI: (01)07615208438703 (11)231117 (10)Z063MW (241)758434 (01)07615208438703 (11)231214 (10)Z067JD(241)758434 Lot Numbers: Z063MW, Z067JD

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94401).

Sources and updates

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