Stryker Instruments Div. of Stryker Corporation recalls Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
- Recall date
- December 4, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1394-2022
- FDA classification
- Class III
- Brand / firm
- Stryker Instruments Div. of Stryker Corporation
- Sold / distributed
- US Nationwide.
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
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