FDA recall Z-1394-2022

Stryker Instruments Div. of Stryker Corporation · Class III · device

Product

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

US Nationwide.

Key facts

Status: Terminated
Initiation date: 2018-12-04
Report date: 2022-07-27
Termination date: 2024-03-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1394-2022