BEUDAMED
    FDA Enforcement Class II Terminated

    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    Recall: Z-2639-2020 · Reported July 22, 2020

    Enforcement

    Recall Number
    Z-2639-2020
    Event ID
    85856
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neocis Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2020
    Initiation Date
    May 14, 2020
    Classification Date
    July 16, 2020
    Termination Date
    July 27, 2021
    Address
    2800 Biscayne Blvd Ste 600, N/A, Miami, FL, 33137-4523, United States

    Description

    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.

    Reason

    The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.

    Code Info

    Work Order (lot): 1623

    Distribution

    US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH

    Quantity

    50 units