Caesarea, Israel
Mazor Robotics Ltd recalls
5 recalls recorded since 2018, most recently on 10 December 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)3
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 December 2025
- Reason
- Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovak
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1122-2026
- Mazor X robotic guidance system REF: TPL0059
Ongoing Class II Medical devices
- Recall started
- 17 July 2024
- 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 screen.
- Distribution
- US Nationwide distribution in PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3156-2024
- Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Ongoing Class II Medical devices
- Recall started
- 5 September 2023
- Reason
- Software update
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0101-2024
- MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Terminated Class II Medical devices
- Recall started
- 2 July 2019
- Terminated
- 2 February 2022
- 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 or neurological deficit/dysfunction
- Distribution
- US: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New York, North Carolina, North Dakota, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0721-2020
- Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Terminated Class II Medical devices
- Recall started
- 26 November 2014
- Terminated
- 3 July 2019
- 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.
- Distribution
- Affected devices were distributed in the US to four different medical facilities in four states
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0609-2019
- 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 implan
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.