BEUDAMED
    FDA Enforcement Class II Ongoing

    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.

    Recall: Z-0963-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0963-2026
    Event ID
    97988
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2025
    Initiation Date
    November 12, 2025
    Classification Date
    December 19, 2025
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.

    Reason

    When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

    Code Info

    Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.

    Quantity

    320 units