Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-1394-2022

Z-1394-2022 Class III Terminated

Recalled by Stryker Instruments Div. of Stryker Corporation — Portage, MI

FDA device recall Z-1394-2022 was initiated by Stryker Instruments Div. of Stryker Corporation on December 4, 2018 and is designated Class III. 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. The recall status is terminated (terminated March 11, 2024). Affected quantity: 51 units.

Recall Details

Product Type
Devices
Report Date
July 27, 2022
Initiation Date
December 4, 2018
Termination Date
March 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51 units

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.

Distribution Pattern

US Nationwide.

Code Information

UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6

Other recalls by Stryker Instruments Div. of Stryker Corporation

  • Z-1452-2022 Class II — SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002 (June 15, 2022)
  • Z-0431-2021 Class II — Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, singl (October 16, 2020)
  • Z-1807-2020 Class II — Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage (March 26, 2020)
  • Z-1402-2022 Class II — Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG (January 22, 2020)
  • Z-1097-2020 Class II — SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The produ (January 13, 2020)
  • Z-1098-2020 Class II — Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is (January 13, 2020)
  • Z-1099-2020 Class II — Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie (January 13, 2020)
  • Z-0592-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0593-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0023-2020 Class II — C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: (July 31, 2019)

FDA data resources