Class 2 Device Recall Nuvasive NVM5 System

• Date Initiated by Firm: June 10, 2020
• Create Date: July 22, 2020
• Recall Status: Terminated on March 22, 2021
• Recall Number: Z-2684-2020
• Recall Event ID: 85889
• 510(K)Number: K143641
• Product Classification: Neurosurgical nerve locator - Product Code PDQ
• Product: Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
• Code Information: Lot 1075097
• Recalling Firm/ Manufacturer: NuVasive Inc; 7475 Lusk Blvd; San Diego CA 92121-5707
• For Additional Information Contact: Customer Service; 858-736-0318
• Manufacturer 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 Determined 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 complaints@nuvasive.com. 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PDQ and Original Applicant = NuVasive, Incorporated