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
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
- Lead & Heavy Metals
- 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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
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
ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaNorth CarolinaNorth DakotaNew YorkPennsylvaniaSouth Carolina
Questions about this recall
Is Snapshot Tracker Kit, Mas2659-01, KIT0898 recalled?
Yes. Mazor Robotics recalled Snapshot Tracker Kit, Mas2659-01, KIT0898 on 2 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-0721-2020.
Why was it recalled?
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
Which lots are affected?
Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496
Where was it sold?
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
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 21 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
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|---|---|---|---|---|---|
| Device | CLASS II | Mazor X robotic guidance system recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Mazor X recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Mazor X robotic guidance system recalled by Mazor Robotics | Mazor Robotics | Device Malfunction | Nationwide |
| Device | CLASS II | Carousel MAS1025-01, part of the Brain Surgical Accessories recalled | Mazor Robotics | Other |
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