FDA Device recall Z-1122-2026
Mazor X robotic guidance system REF: TPL0059
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of Mazor X robotic guidance system REF: TPL0059 by Mazor Robotics, citing software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1122-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-10 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Mazor Robotics |
| Distribution | US |
Product
Mazor X robotic guidance system REF: TPL0059
Reason
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Identifiers
| code_info | Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 0729010918…Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1122-2026%22
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