Class I - Dangerous
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.
NuVasive
36 recalls • • Categories: Infusion Pumps, Other Medical Devices, Diagnostic Equipment, Implants & Prosthetics
Class I - Dangerous
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
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.
Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.