Stryker recalls Triton Sponge System software versions 4.6.5, 4.8.7, and 4.9.6 for updated instructions on sponge handling and calibration placards.
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.
Stryker is recalling specific software versions of their Triton Sponge System to clarify proper sponge handling techniques and calibration placard procedures. This update aims to improve safety and reduce confusion during surgical procedures.
The recall involves updating instructions for proper sponge handling and calibration placard procedures. This update clarifies techniques to prevent potential errors during surgical sponge management.
Surgical teams using the Triton Sponge System with software versions 4.6.5, 4.8.7, or 4.9.6 are affected. Surgeons and surgical staff handling sponges during procedures are most at risk.
Check if your Triton Sponge System software is version 4.6.5, 4.8.7, or 4.9.6. The product has a UDI-DI (GTIN) number 00859506006067.
Review your Triton Sponge System software version to confirm if it is 4.6.5, 4.8.7, or 4.9.6.
Stryker is updating the Instructions for Use to clarify proper sponge handling techniques and calibration placard procedures.
The recall does not require immediate action; it is a clarification of instructions for safer use.
Software versions 4.6.5, 4.8.7, and 4.9.6 of the Triton Sponge System.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1394-2022 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1394-2022 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
