BEUDAMED
    FDA Enforcement Class II Terminated

    BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

    Recall: Z-2897-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2897-2016
    Event ID
    75082
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Prismatik Dentalcraft, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2016
    Initiation Date
    August 15, 2016
    Classification Date
    September 27, 2016
    Termination Date
    December 23, 2016
    Address
    2181 Dupont Dr, N/A, Irvine, CA, 92612-1301, United States

    Description

    BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

    Reason

    Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.

    Code Info

    BZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614

    Distribution

    Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY

    Quantity

    150 units