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Recall Observatory FDA recall evidence

Device product

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

Z-2684-2020

June 10, 2020

Class II

Product summary

Firm
NuVasive Inc
Event
Event 85889
Status
Terminated
Classification
Class II
Quantity
23
Official record key
device-enforcement:Z-2684-2020

Official wording

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.

Code information: Lot 1075097

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.