Recall Z-0609-2019 ยท HAW Neurological Stereotaxic Instrument
Mazor Robotics Ltd
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
| Date | Nov 26, 2014 |
| Status | Terminated |
| Reason | In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. |
| Root cause | Device Design |
| Action | All Mazor Brain Clinical Sales Representatives (support during clinical cases) were notified of the issue on 11/26/2014 via email as well as received training. |
| Quantity | 5 units |
| Distribution | Affected devices were distributed in the US to four different medical facilities in four states |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120812 | RENAISSANCE Mazor Robotics , Ltd., Jul 12, 2012 |