Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-1394-2022

Z-1394-2022 Class III Terminated

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

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
December 4, 2018
Termination Date
March 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

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