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Z-1394-2022 Class III Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-1394-2022 was initiated by Stryker Instruments Div. Of Stryker Corporation on Dec 4, 2018 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated Mar 11, 2024). Affected quantity: 51 units.

Recall Details

Product Type: Devices
Report Date: Jul 27, 2022
Initiation Date: Dec 4, 2018
Termination Date: Mar 11, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 51 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

US Nationwide.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1394-2022
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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