BEUDAMED
    FDA Enforcement Class II Ongoing

    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

    Recall: Z-1706-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1706-2024
    Event ID
    94401
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    IVOCLAR VIVADENT AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 8, 2024
    Initiation Date
    April 5, 2024
    Classification Date
    April 30, 2024
    Address
    BEDERSRASSE, LIECHTSTEIN, N/A, Germany

    Description

    IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439

    Reason

    Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration

    Code Info

    UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439; (01)07615208438659 (11)231214 (10)Z067JC (241)758439; (01)07615208438659 (11)231214 (10)Z067JG (241)758439; (01)07615208438659 (11)231214 (10)Z067JB (241)758439; (01)07615208438659 (11)240105 (10)Z06B6Z (241)758439; (01)07615208438659 (11)240112 (10)Z06CBG (241)758439 Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG

    Distribution

    US Nationwide distribution.

    Quantity

    12525 units