Nuvasive NVM5 EMG Module Recalled for Incorrect Component
NuVasive Inc is recalling 23 NVM5 EMG Modules because they contain an incorrect SSEP harness instead of the correct NVM5 Harness, potentially delaying spinal surgery monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a delay in therapy or lack of monitoring rather than direct physical injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
NuVasive Inc is recalling 23 units of the NVM5 EMG Module, REF 8020015, intended for intraoperative neurophysiologic monitoring during spinal surgery. The recall is due to the presence of an incorrect component, part number 1715945 (SSEP harness), instead of the correct part number 1747065 (NVM5 Harness, Gen 3.5 EM).
The affected units were distributed nationwide in the United States, including in Arkansas, California, Iowa, Illinois, and Wisconsin. No units were distributed outside the US. The specific lot number is 1075097.
This issue can result in a delay in therapy or a lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
- Manufacturer
- NuVasive Inc
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1075097
Distribution
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