Reported Jul 29, 2020 · Terminated
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended…
NuVasive Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NuVasive Inc · 7475 Lusk Blvd · San Diego, CA · 92121-5707
Is this the product you have?
Nuvasive NVM5 EMG ModuleREF 8020015Rx ONLYCE2797Nonsterile
- UDI00887517206633 -
- Product Usageis intended for intraoperative neurophysiologic monitoring during spinal surgery
- Lot codes and dates
- Lot 1075097
- Amount recalled
- 23
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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