CLASS II Device recall · Reported 1 Jan 2020 · FDA Enforcement Report

Snapshot Tracker Kit, Mas2659-01, KIT0898 recalled by Mazor Robotics

Mazor Robotics is recalling Snapshot Tracker Kit, Mas2659-01, KIT0898, distributed in 26 states. The recall was initiated on 2 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496

Quantity recalled93 snapshot trackers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0721-2020
FDA event ID: 84328
Recalling firm: Mazor Robotics, Caesarea
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2019
FDA classified: 20 Dec 2019
Reported: 1 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Jul 2019	Recall initiated by company
20 Dec 2019	Classified by FDA	+171 days
1 Jan 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

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

Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota North Carolina North Dakota New York Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mazor Robotics

All 5

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	Mazor X robotic guidance system recalled by Mazor Robotics	Mazor Robotics	Device Malfunction	Nationwide
25 Sep 2024Device	CLASS II	Mazor recalled by Mazor Robotics	Mazor Robotics	Device Malfunction	Nationwide
18 Oct 2023Device	CLASS II	Mazor X robotic guidance system recalled by Mazor Robotics	Mazor Robotics	Device Malfunction	Nationwide
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