Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Summary
The FDA issued a Class III for Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 by Stryker Instruments Div. of Stryker Corporation. Reason: Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and t.
Details
Source
Device Recall
External ID
Z-1394-2022
Action Date
2022-07-27
Status
Terminated
Category
device
Product Description
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Lot/Code Info: UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6
Quantity Affected: 51 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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2018-12-04
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Instruments Div. of Stryker Corporation has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Instruments Div. of Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Instruments Div. of Stryker Corporation have FDA actions?
Stryker Instruments Div. of Stryker Corporation has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1394-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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