Recall Z-0024-2020 ยท ETN Stimulator, Nerve
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Jul 31, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On July 31, 2019, the firm distributed an Urgent Medical Device Recall Notification to its consignees to inform them of the recall. Customers were asked to do the following: 1. Immediately review the Recall Notification and this Business Reply Form (BRF). 2. Inform all users of the Stryker C2 NerveMonitor of the information contained in this recall notification. 3. Check all treatment areas, operating rooms and/or storage areas for affected products. 4. Determine a plan to transition to an alternative commercially available product. Document your transition date on the BRF. This transition d |
| Quantity | 135 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152505 | C2 NerveMonitor System Inomed Medizintechnik GmbH, Feb 1, 2016 |