Mazor Robotics

4 recalls •

• Categories: Surgical Instruments, Other Medical Devices, Implants & Prosthetics

Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

Class I - Dangerous

Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.

Jul 17, 2024 Surgical Instruments Nationwide View Details →

MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1

Class I - Dangerous

Software update

Sep 5, 2023 Other Medical Devices Nationwide View Details →

Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868

Class I - Dangerous

The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological deficit/dysfunction

Jul 2, 2019 Other Medical Devices View Details →

Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

Class I - Dangerous

In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.

Nov 26, 2014 Implants & Prosthetics View Details →