Recall Z-0721-2020— Mazor Robotics Ltd
Class II · Terminated
Class II FDA medical device recall by Mazor Robotics Ltd, initiated 2019-07-02, terminated 2022-02-02. It names one FDA 510(k) clearance: K182077. 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.
- Recalling firm
- Mazor Robotics Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-02
- Terminated
- 2022-02-02
- Firm location
- Caesarea, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.