Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1394-2022

December 04, 2018

Class III

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 90448
Status
Terminated
Classification
Class III
Quantity
51 units
Official record key
device-enforcement:Z-1394-2022

Official wording

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

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.