# FDA recall Z-2684-2020

> **NuVasive Inc** · Class II · device recall initiated 2020-06-10.

## 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.

## Distribution

US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS:  None

## Key facts

- **Recall number:** Z-2684-2020
- **Recalling firm:** NuVasive Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-10
- **Report date:** 2020-07-29
- **Termination date:** 2021-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2684-2020

## Citation

> AI Analytics. FDA recall Z-2684-2020. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2684-2020. Source: US FDA. Licensed CC0.

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