Mazor Robotics Ltd 2023-10-18 Health serious FDA
Health · FDA · Recall #FDA-Z-0101-2024
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 Recall
Issued October 18, 2023 · Mazor Robotics Ltd
In October 2023, Mazor Robotics Ltd recalled the MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Software update
What you should do
- 1 Stop using MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Mazor Robotics Ltd to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Mazor Robotics Ltd
- Category
- Health
- Recall date
- October 18, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0101-2024
- Made in
- Israel
- Issuing agency
- FDA
In context
- Mazor Robotics Ltd has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.