Mazor Robotics recalls
Mazor Robotics appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-28.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2018-12-26 to 2026-01-28 |
| By agency | FDA Device (5) |
| By classification | Class II (5) |
| By status | ongoing (3), terminated (2) |
| Distribution named in notices | AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NY, PA, SC, SD, TN, TX, US, UT, VA, WV |
Recalls
- Mazor X robotic guidance system REF: TPL0059
FDA Device · Class II · 2026-01-28 · Mazor Robotics
Reason: Software errors that can result in incorrect surgical instrument positioning during spinal surgery. - Mazor X. Model Number REF TPL0059
FDA Device · Class II · 2024-09-25 · Mazor Robotics
Reason: 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 s… - MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
FDA Device · Class II · 2023-10-18 · Mazor Robotics
Reason: Software update - Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
FDA Device · Class II · 2020-01-01 · Mazor Robotics
Reason: 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… - Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0…
FDA Device · Class II · 2018-12-26 · Mazor Robotics
Reason: In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.