BEUDAMED
    FDA Enforcement Class II Terminated

    Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

    Recall: Z-1485-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1485-2018
    Event ID
    79749
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 13, 2018
    Classification Date
    April 24, 2018
    Termination Date
    July 23, 2018
    Address
    154 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    Description

    Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

    Reason

    The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.

    Code Info

    lot #s 38177 38330 38421

    Distribution

    USA (nationwide) Distribution and Internationally to Turkey.

    Quantity

    19