FDA recall Z-0023-2020

Stryker Instruments Div. of Stryker Corporation · Class II · device

Product

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

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2019-07-31
Report date
2019-10-09
Termination date
2021-03-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0023-2020