BEUDAMED
    FDA Enforcement Class II Ongoing

    TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;

    Recall: Z-1561-2025 · Reported April 23, 2025

    Enforcement

    Recall Number
    Z-1561-2025
    Event ID
    96516
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Straumann USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2025
    Initiation Date
    March 8, 2025
    Classification Date
    April 14, 2025
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008, United States

    Description

    TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;

    Reason

    The devices are missing the laser marked depth markings.

    Code Info

    REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, United Kingdom.

    Quantity

    45 units