Recall Z-3156-2024 ยท OLO Orthopedic Stereotaxic Instrument
Mazor Robotics Ltd
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
| Date | Sep 16, 2024 (initiated Jul 17, 2024) |
| Status | Open, Classified |
| Reason | Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen. |
| Root cause | Device Design |
| Action | Medtronic/Mazor Robotics, Ltd. issued an URGENT: Medical Device Software Correction to its consignees on 07/17/2024 via 2-day tracked mailing. The notice explained the issue, potential risk, and provided a workaround until the software update is installed. Medtronic will schedule a time to perform a software update that will resolve these anomalies. Medtronic field service engineers will update all Mazor X systems from version 5.1.1 to version 5.1.2 or later. Questions: contact Medtronic Technical Services at 1-888-826-5603 or rs.navtechsupport@medtronic.com . |
| Quantity | 94 devices |
| Distribution | US Nationwide distribution in PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230064 | Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd., Apr 7, 2023 |