BEUDAMED
    FDA Enforcement Class III Terminated

    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

    Recall: Z-1394-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1394-2022
    Event ID
    90448
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    December 4, 2018
    Classification Date
    July 15, 2022
    Termination Date
    March 11, 2024
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

    Reason

    Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.

    Code Info

    UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6

    Distribution

    US Nationwide.

    Quantity

    51 units