Home / Recalls / NuVasive Inc / Z-1052-2023

Z-1052-2023 Class III Ongoing

Recalled by NuVasive Inc — San Diego, CA

Recall Details

Product Type
Devices
Report Date
February 15, 2023
Initiation Date
July 19, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7

Product Description

NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US

Reason for Recall

Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

Distribution Pattern

U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.

Code Information

Part Number: 1881500 UDI Code: 0887517PLS137YJ Serial Numbers: PM00017 SM90018 SM90013 SM90021 PM00007 SM90032 SM90030

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-1453-2022 Class II — Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6 (June 20, 2022)
  • Z-2684-2020 Class II — Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 008875 (June 10, 2020)
  • 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-0362-2013 Class II — 7.5mm x 35mm Cannulated 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-0370-2013 Class II — 5.5mm x 40mm Noncannulated 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-0352-2013 Class II — 5.5mm x 45mm 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)