PlainRecalls
FDA Devices Moderate Class II Terminated

Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.

Reported: July 29, 2020 Initiated: June 10, 2020 #Z-2684-2020

Product Description

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.

Details

Recalling Firm
NuVasive Inc
Units Affected
23
Distribution
US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.. Recalled by NuVasive Inc. Units affected: 23.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2684-2020.