Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
FDA device recall Z-3156-2024 · posted 2024-09-16 · Open, Classified
Recall details
- Recalling firm
- Mazor Robotics Ltd
- Reason for recall
- 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.
- Action taken
- 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 .
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 94 devices
- Distribution
- US Nationwide distribution in PR.
- Date initiated
- 2024-07-17
- Date posted
- 2024-09-16
- Location
- Caesarea, Israel
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Mazor X System (Mazor X Stealth Edition) (K230064) | Mazor Robotics , Ltd. | 2023-04-07 |