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

Recall Insight

This FDA Devices action (record #Z-2684-2020) was formally reported on July 29, 2020, with the manufacturer initiating the action on June 10, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. NuVasive Inc is listed as the recalling firm, operating out of San Diego, CA. Federal records indicate 23 units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.