BEUDAMED
    FDA Enforcement Class II Ongoing

    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

    Recall: Z-0630-2024 · Reported January 10, 2024

    Enforcement

    Recall Number
    Z-0630-2024
    Event ID
    93522
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Keystone Industries
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 10, 2024
    Initiation Date
    November 20, 2023
    Classification Date
    January 3, 2024
    Address
    480 S Democrat Rd, N/A, Gibbstown, NJ, 08027-1239, United States

    Description

    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

    Reason

    Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).

    Code Info

    UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628

    Distribution

    Worldwide distribution - US Nationwide and the country of China.

    Quantity

    336 units