BEUDAMED
    FDA Enforcement Class II Ongoing

    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.

    Recall: Z-2172-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2172-2025
    Event ID
    96778
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    May 1, 2025
    Classification Date
    July 25, 2025
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171, United States

    Description

    The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.

    Reason

    The Drill stop kit contains incorrect components.

    Code Info

    Lot # 15006511/UDI: (10)841307125310

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ, NV, NY, OH, OK, TN, TX, UT, VA and the country of Japan.

    Quantity

    45 Kits