Z-2684-2020 Class II Terminated
FDA device recall Z-2684-2020 was initiated by NuVasive Inc on June 10, 2020 and is designated Class II. 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 nu… The recall status is terminated (terminated March 22, 2021). Affected quantity: 23.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2020
- Initiation Date
- June 10, 2020
- Termination Date
- March 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Product Description
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
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.
Distribution Pattern
US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None
Code Information
Lot 1075097