NuVasive recalls NVM5 EMG Module (REF 8020015) due to incorrect component causing potential delay in spinal surgery monitoring. Affected units have specific model and lot numbers.
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.
NuVasive is recalling its NVM5 EMG Module for spinal surgery use because it contains the wrong component. This could delay therapy or prevent proper neuromonitoring during surgery if the surgeon proceeds without the correct module.
The module contains part number 1715945 (SSEP harness) instead of the correct part number 1747065 (NVM5 Harness, Gen 3.5 EM). This incorrect component may cause delays in therapy or prevent proper neuromonitoring during spinal surgery if the surgeon continues without the correct module.
Surgeons and medical staff performing spinal surgery who use the NVM5 EMG Module for intraoperative neurophysiologic monitoring. Those who have the specific model and lot number are most at risk.
Check for the product name 'Nuvasive NVM5 EMG Module', reference number 8020015, and lot number 1075097. The product is intended for use during spinal surgery with specific medical authorization.
Check the product label for reference number 8020015 and lot number 1075097 to confirm if it is affected.
The NVM5 EMG Module contains the incorrect component (part number 1715945 SSEP harness) instead of the correct part number 1747065 NVM5 Harness, Gen 3.5 EM. This could delay therapy or prevent proper neuromonitoring during surgery.
Check the product label for reference number 8020015 and lot number 1075097. If it matches, contact NuVasive for guidance on next steps.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send NuVasive to request your refund or repair — edit it as you like.
Subject: Recall Z-2684-2020 — NuVasive NuVasive Hello, I own a NuVasive that is covered by recall Z-2684-2020 from NuVasive. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
