Z-2684-2020Class II

Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 -

Name: Z-2684-2020 Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 -
Creator: NuVasive Inc
Published: 2020-06-10
License: https://open.fda.gov/license/

NuVasive Inc / initiated 2020-06-10 / Terminated

FDA source

NuVasive Inc began a recall of Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic... on 2020-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2684-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-10
Posted: 2020-07-22
Terminated: 2021-03-22
Recalling firm: NuVasive Inc
Product: Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
Product code: PDQ Neurosurgical Nerve Locator
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Affected customers at hospitals were notified through Urgent Medical Device Recall Notification NVM5 EMG Module dated June 10, 2020 via email on 6/10/2020 and 6/23/2020 (one of seven customers). Each customer received a Return Material Authorization (RMA) for traceability purposes. The Recall Notification was directed to the affected customer population by way of email. Communication included a Consignee Confirmation Form as well as the following email address [email protected]. Once a response is received, NuVasive, as the distributor, will provide the reporter with an acknowledgement email confirming receipt.Within the Recall Notification emailed to customers a set of instructions to follow was included: Immediately examine your inventory to determine if you have product subject to this action on hand and quarantine the product. Further attempt to use kits with this lot number shall cease immediately. To identify the affected product, search for the lot number as indicated in Figure 1. Only Lot Number 1075097 is affected by this recall. NuVasive has provided a replacement kit which should have been received by the time this notification is received. Your NuVasive representative will be visiting your office or contacting you directly to provide instructions for the return of the affected kits. All kits received by your organization shall be returned to NuVasive per the instructions provided by your NuVasive representative. Review, complete, sign (via DocuSign) and return the attached Consignee Confirmation Form accompanying this notification in accordance with the directions on the form. Forward this notice to anyone in your facility that needs to be informed.
Quantity in commerce: 23
Distribution: US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None
Product codes and lots: Lot 1075097

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2684-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2684-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-22

Product code PDQ

K143641Class IINuVasive NVM5 SystemNu Vasive, Incorporated / cleared 2015-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)