BEUDAMED
    FDA Enforcement Class II Terminated

    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    Recall: Z-0929-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0929-2021
    Event ID
    87060
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neocis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 3, 2021
    Initiation Date
    October 30, 2020
    Classification Date
    January 26, 2021
    Termination Date
    August 11, 2021
    Address
    530 NW 29th St, Miami, FL, 33127-3917, United States

    Description

    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

    Reason

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

    Code Info

    Work Order (Lot) Number 1573

    Distribution

    OH, FL, CT, MA, AZ PA, NY

    Quantity

    100 units