Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-0023-2020

Z-0023-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 9, 2019
Initiation Date
July 31, 2019
Termination Date
March 24, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
135

Product Description

C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

Reason for Recall

Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.

Distribution Pattern

US Nationwide distribution.

Code Information

All Serial Numbers are affected

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-1099-2020 Class II — Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie (January 13, 2020)
  • Z-1098-2020 Class II — Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is (January 13, 2020)
  • Z-1097-2020 Class II — SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The produ (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-0024-2020 Class II — C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: (July 31, 2019)