NuVasive Inc: Medical Device Recall in 2020 - (Recall #: Z-2684-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
Class II
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.
Lot 1075097
US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None
Voluntary: Firm initiated