FDA Device recall Z-0721-2020
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 by Mazor Robotics, citing 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 res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0721-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-02 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Mazor Robotics |
| Distribution | AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NY, PA, SC, SD, TN, TX, UT, VA, WV |
Product
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Reason
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
Identifiers
| code_info | Lot Numbers: 070494, 070548, 070551, 070481, 070490, 070495, 070542, 070496 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2026-01-28 · Mazor Robotics - Mazor X. Model Number REF TPL0059
FDA Device · Class II · 2024-09-25 · Mazor Robotics - MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
FDA Device · Class II · 2023-10-18 · Mazor Robotics - Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0…
FDA Device · Class II · 2018-12-26 · Mazor Robotics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0721-2020%22
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