Home / Recalls / NuVasive Inc / Z-2684-2020

Z-2684-2020 Class II Terminated

Recalled by NuVasive Inc — San Diego, CA

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

Other recalls by NuVasive Inc

  • Z-0738-2023 Class II — X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System use (November 10, 2022)
  • Z-1052-2023 Class III — NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version (July 19, 2022)
  • Z-1453-2022 Class II — Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6 (June 20, 2022)
  • Z-1898-2020 Class II — NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usa (February 13, 2020)
  • Z-0370-2013 Class II — 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0362-2013 Class II — 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0355-2013 Class II — 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0372-2013 Class II — 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0363-2013 Class II — 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)
  • Z-0369-2013 Class II — 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI (January 5, 2009)