Device product
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 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.
Z-0024-2020
Product summary
- Event
- Event 83490
- Status
- Terminated
- Classification
- Class II
- Quantity
- 135
- Official record key
device-enforcement:Z-0024-2020
Official wording
Reason: 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.
Code information: All Serial Numbers are affected
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.