BEUDAMED
    FDA Enforcement Class II Terminated

    Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.

    Recall: Z-2943-2020 · Reported September 16, 2020

    Enforcement

    Recall Number
    Z-2943-2020
    Event ID
    86227
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Talladium Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 16, 2020
    Initiation Date
    August 6, 2020
    Classification Date
    September 9, 2020
    Termination Date
    October 7, 2022
    Address
    27360 Muirfield Ln, Valencia, CA, 91355-1010, United States

    Description

    Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.

    Reason

    The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range.

    Code Info

    Lot Number.: 1AZG

    Distribution

    U.S. Nationwide distribution including in the states of CA, FL, KS, LA, MO, and PA. No OUS Consignees.

    Quantity

    39 pieces