Recall Z-1394-2022— Stryker Instruments Div. of Stryker Corporation
Class III · Terminated
Class III FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2018-12-04, terminated 2024-03-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6. 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..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-12-04
- Terminated
- 2024-03-11
- Firm location
- Portage, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.