Mazor Robotics Ltd
Active in EUDAMEDIsraelfrom SRN EUDAMED SRN IL-MF-000020000
Mazor Robotics Ltd is a medical device manufacturer based in Israel, with 536 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb and I) and 5 FDA recalls as of 13 Nov 2026.
- Devices
- 536
- Registrations
- EUDAMED
- FDA recalls
- 53 ongoing
Registry facts
- Registries
- FDA GUDID 526
- EUDAMED 61
- FDA 510(k) 8
- Device classes
- FDA Class II 488
- EU Class IIb 39
- EU Class I 9
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Medtronic B.V. authorised representative
- Identifiers
- EUDAMED SRN IL-MF-000020000
- DUNS 532681590
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Medtronic B.V.NL
What Mazor Robotics Ltd makes
The company manufactures reusable and single-use surgical instruments and systems for stereotactic and orthopaedic procedures, including robotic frame connection kits, cranial drill bits, and specialized clamps like the muscle biopsy clamp. Their portfolio also includes general and orthopaedic surgical procedure kits, patient drapes, and reusable instrument trays designed for precision-guided surgeries. Multi-purpose stereotactic systems and spinal instrumentation, such as guiding adaptors and Schanz screws, are also part of their offerings.
All listed devices fall under Class II regulatory classification and are registered in the FDA’s Unique Device Identifier (UDI) database. The company is based in Israel and adheres to relevant international standards for surgical and orthopaedic instrumentation.
Catalogue
Search and filter all 536 devicesShowing 1-50 of 536
Company details
- EUDAMED SRN
- IL-MF-000020000
- SRN (system / procedure pack)
- IL-PR-000014544
- DUNS number
- 532681590
- EUDAMED status
- Active
- EUDAMED registered name
- Mazor Robotics Ltd.
- Registered address
- 1, HaEshel Street (Building C), Caesarea Business Park, 3079830, Caesarea, Israel
- Phone
- +97246187100
- PRRC contact
- Marina Hefetz Lerner
FDA recalls
FDA recall records list 5 recalls initiated by MAZOR ROBOTICS LTD, the earliest on 2014-11-26 and the most recent on 2025-12-10. By recorded status: 3 ongoing and 2 terminated. The reasons filed fall into these groups: software or firmware, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 1
- 2025 1
- 2026 0
2025
- 10 Dec 2025 Z-1122-2026 Class II Ongoing Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Full distribution text
- 10 Dec 2025 Z-1122-2026 Class II Ongoing Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
2024
- 17 Jul 2024 Z-3156-2024 Class II Ongoing 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.
2023
- 5 Sep 2023 Z-0101-2024 Class II Ongoing Software update
2019
- 2 Jul 2019 Z-0721-2020 Class II Terminated 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
Full distribution text
- 2 Jul 2019 Z-0721-2020 Class II Terminated 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
2014
- 26 Nov 2014 Z-0609-2019 Class II Terminated In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Frequently asked questions
How many devices does MAZOR ROBOTICS LTD have in the registry?
The registry currently lists 536 devices for MAZOR ROBOTICS LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list MAZOR ROBOTICS LTD's devices?
Among its 50 most recently registered devices, MAZOR ROBOTICS LTD has devices listed in EUDAMED (3 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MAZOR ROBOTICS LTD's devices fall under?
Among its 50 most recently registered devices, the classes recorded for MAZOR ROBOTICS LTD's devices are Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for MAZOR ROBOTICS LTD?
FDA recall records list 5 recalls initiated by MAZOR ROBOTICS LTD, the most recent initiated on 10 Dec 2025. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from MAZOR ROBOTICS LTD in the registry?
The most recently registered devices listed for MAZOR ROBOTICS LTD include MAZOR X Stealth Edition, Surgical System Sleeve, 10 Pack KIT0953-04, Robotic Frame Connection Kit KIT0899-04 and Head Pin 2.5x60mm, 10 pack w/o CE KIT0001796-01.