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U.S. Department of Health and Human Services

Class 3 Device Recall Triton Sponge System

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  Class 3 Device Recall Triton Sponge System see related information
Date Initiated by Firm December 04, 2018
Create Date July 15, 2022
Recall Status1 Terminated 3 on March 11, 2024
Recall Number Z-1394-2022
Recall Event ID 90448
Product Classification Scale, surgical sponge - Product Code FQA
Product Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Code Information UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Jordan Greegor
269-539-7085
Manufacturer 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.
FDA Determined
Cause 2		 Use error
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.
Quantity in Commerce 51 units
Distribution US Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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