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Terminated

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

FDA Recall Z-1394-2022 · Posted None

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFQA
Date Initiated2018-12-04
Date Terminated2024-03-11
Product Quantity51 units

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.

Firm Action

Gauss notified customers with a notification letter dated Dec 4, 2018. The letter informed customers that the IFU would be updated in order to clarify proper technique for handling sponges and the calibration placard. No action was required by the customer as the IFU updates were automatically accessible to the user through the iPad application and automatically moved to the newest revision.

Root Cause

Use error

Distribution Pattern

US Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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