Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), access...
FDA Device Recall #Z-0609-2019 — Class II — November 26, 2014
Recall Summary
| Recall Number | Z-0609-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 26, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mazor Robotics Ltd |
| Location | North Industrial Park |
| Product Type | Devices |
| Quantity | 5 units |
Product Description
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.
Reason for Recall
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 Pattern
Affected devices were distributed in the US to four different medical facilities in four states
Lot / Code Information
Affected products: all Carousels under Level 01 were affected and therefore are applicable to this issue. The related lots include: WP065611, WP066389, WP066411, WP066412, WP066420. Explanation of the coding system: a part number (e.g. MAS1025-01) is composed of a generic part number related to the part (e.g. MAS1025) and the level of the part (e.g. 01).
Other Recalls from Mazor Robotics Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1122-2026 | Class II | Mazor X robotic guidance system REF: TPL0059 | Dec 10, 2025 |
| Z-3156-2024 | Class II | Mazor X. Model Number REF TPL0059; stereotaxic ... | Jul 17, 2024 |
| Z-0101-2024 | Class II | MAZOR X robotic guidance system, Model TPL0059,... | Sep 5, 2023 |
| Z-0721-2020 | Class II | Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx O... | Jul 2, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.