BEUDAMED
    FDA Enforcement Class II Terminated

    Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021

    Recall: Z-1062-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1062-2019
    Event ID
    82374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 3, 2019
    Initiation Date
    February 22, 2019
    Classification Date
    March 27, 2019
    Termination Date
    June 19, 2020
    Address
    154 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    Description

    Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021

    Reason

    Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

    Code Info

    Lot Numbers: WO-010366

    Distribution

    FL, MA, SC, VA

    Quantity

    1 hex Driver