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.
Reported: October 9, 2019 Initiated: July 31, 2019 #Z-0023-2020
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.
Details
- Recalling Firm
- Stryker Instruments Div. of Stryker Corporation
- Units Affected
- 135
- Distribution
- US Nationwide distribution.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 135.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2019. Severity: Moderate. Recall number: Z-0023-2020.
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