FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
- Recall number
- Z-1394-2022
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
- Status
- Terminated
- Initiated
- 2018-12-04
- Posted
- not on file
- Terminated
- 2024-03-11
- 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 the calibration placard.
- Root cause
- 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
- 51 units
- Distribution
- US Nationwide.
- Lot, serial or model codes
- UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQA
- Firm FEI
- 1811755
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28