Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1703-2024 — 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

U.S. FDA — Device Enforcement · Germany · 2024-04-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1703-2024
Date of alert
2024-04-05
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
IVOCLAR VIVADENT AG
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07615208438703
Reported risk: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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