Recall Z-2684-2020 ยท PDQ Neurosurgical Nerve Locator
NuVasive Inc
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
| Date | Jun 10, 2020 |
| Status | Terminated |
| Reason | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in therapy or lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5. |
| Root cause | Under Investigation by firm |
| Action | Affected customers at hospitals were notified through Urgent Medical Device Recall Notification NVM5 EMG Module dated June 10, 2020 via email on 6/10/2020 and 6/23/2020 (one of seven customers). Each customer received a Return Material Authorization (RMA) for traceability purposes. The Recall Notification was directed to the affected customer population by way of email. Communication included a Consignee Confirmation Form as well as the following email address complaints@nuvasive.com. Once a response is received, NuVasive, as the distributor, will provide the reporter with an acknowledgemen |
| Quantity | 23 |
| Distribution | US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143641 | NuVasive NVM5 System Nu Vasive, Incorporated, Mar 27, 2015 |