Nuvasive NVM5 EMG Module — Class II medical device recall Z-2684-2020
Terminated recall by NuVasive Inc, reported 2020-07-29, distributed nationwide. The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains
| Recall number | Z-2684-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NuVasive Inc, San Diego, CA, United States |
| Recall initiated | 2020-06-10 |
| Classified | 2020-07-22 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2021-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 23 |
| UPC / GTIN / UDI-DI | 00887517206633 |
| Lot numbers | 1075097 |
| Model numbers | 8020015 |
Product
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2684-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.