Z-0023-2020 Class II Terminated
FDA device recall Z-0023-2020 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jul 31, 2019 and is designated Class II. 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… The recall status is terminated (terminated Mar 24, 2021). Affected quantity: 135.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2019
- Initiation Date
- Jul 31, 2019
- Termination Date
- Mar 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0023-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026