FDA Device recall Z-0101-2024
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 by Mazor Robotics, citing software update.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0101-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-05 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mazor Robotics |
| Distribution | US |
Product
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Reason
Software update
Identifiers
| code_info | GTIN 07290109180465, Serial Numbers: 4000770717, 4000800717, 4000810817, 4000820817, 4000830817, 4000840817, 400085081…GTIN 07290109180465, Serial Numbers: 4000770717, 4000800717, 4000810817, 4000820817, 4000830817, 4000840817, 4000850817, 4000870817, 4000880817, 4000890917, 4000900917, 4000910917, 4000920917, 4000930917, 4000940917, 4000951017, 4000961017, 4000971017, 4000981017, 4000991017, 4001001017, 4001011117, 4001041117, 4001061117, 4001071217, 4001081217, 4001091217, 4001101217, 4001111217, 4001121217, 4001130118, 4001140118, 4001150118, 4001160118, 4001180118, 400-26-112016, 400-27-112016, 400-29-122016, 400-30-122016, 400-31-122016, 400-36-122016, 400-38-122016, 400-44-022017, 400-47-022017, 400-48-022017, 400-50-032017, 400-51-032017, 400-53-032017, 400-54-032017, 400-55-032017, 400-56-032017, 400-59-052017, 400-60-052017, 400-61-062017, 400-63-062017, 400-64-062017, 400-65-062017, 400-67-062017, 400-68-062017, 400-69-062017, 400-71-062017, 400-72-062017, 400-73-062017, 400-75-062017, 400-78-072017, 400-79-072017; GTIN 07290109181158, Serial Numbers: 4001200218, 4001210218, 4001270318, 40 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0101-2024%22
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