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

FDA Device Recall #Z-0721-2020 — Class II — July 2, 2019

Recall Summary

Recall Number Z-0721-2020
Classification Class II — Moderate risk
Date Initiated July 2, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mazor Robotics Ltd
Location Caesarea
Product Type Devices
Quantity 93 snapshot trackers

Product Description

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

Reason for Recall

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 Pattern

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

Lot / Code Information

Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496

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-0609-2019 Class II Carousel MAS1025-01, part of the Brain Surgical... Nov 26, 2014

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.