FDA Device recall Z-3156-2024
Mazor X. Model Number REF TPL0059
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of Mazor X. Model Number REF TPL0059 by Mazor Robotics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3156-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-17 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mazor Robotics |
| Distribution | US |
Product
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
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.
Identifiers
| code_info | UDI/DI 07290109180465, Lot Numbers: 400-38-122016, 400-44-022017, 400-67-062017, 400-69-062017; UDI/DI 07290109181158…UDI/DI 07290109180465, Lot Numbers: 400-38-122016, 400-44-022017, 400-67-062017, 400-69-062017; UDI/DI 07290109181158, Lot Numbers: 4001200218, 4001970419, 4001011117, 4001041117, 4001061117, 4001320518, 4001330618, 4001390818, 4001430918, 4001631218, 4001690119, 4001710119, 4001780219, 4001790219, 4001800219, 4001960419, 4001980419, 4002050419R, 4002170619, 4002230819, 4002240819, 4002310919, 4002511119, 4002531119, 4002541119, 4002591119, 4002641219, 4002661219, 4002850220, 4002860220R, 4002900220, 4003020320, 4003030320, 4003180320, 4003190320, 4003430920, 4006951223, 4006901223, 4006890923, 4006860923, 4006830923, 4006680723, 4006170323, 4006090223, 4006050223, 4006040223, 4005210922, 4005770123, 4005720123, 4005431122, 4005750123, 4006130323, 4004091121; UDI/DI 07290109184098, Lot Numbers: 4003840821, 4003860821, 4004151121, 4004231221, 4004290122, 4004310122; UDI/DI 07290115751376, Lot Numbers: 4004860522, 4005180822, 4004670322, 4004700322, 4004870522, 4005080722, 4005130 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3156-2024%22
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