Mazor X — Class II medical device recall Z-3156-2024
Ongoing recall by Mazor Robotics Ltd, reported 2024-09-25, distributed nationwide. Software anomalies which can result in two separate issues: A lagging screen display during a navigated proced
| Recall number | Z-3156-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mazor Robotics Ltd, Caesarea, Israel |
| Recall initiated | 2024-07-17 |
| Classified | 2024-09-16 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 94 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07290109180465, 07290109181158, 07290109184098, 07290115751376 |
| Lot numbers | 400-38-122016, 400-44-022017, 400-67-062017, 400-69-062017, 4001011117, 4001041117, 4001061117, 4001200218, 4001320518, 4001330618, 4001390818, 4001430918, 4001631218, 4001690119, 4001710119, 4001780219, 4001790219, 4001800219, 4001960419, 4001970419, 4001980419, 4002050419R, 4002170619, 4002230819, 4002240819, 4002310919, 4002511119, 4002531119, 4002541119, 4002591119, 4002641219, 4002661219, 4002850220, 4002860220R, 4002900220, 4003020320, 4003030320, 4003180320, 4003190320, 4003430920 and 54 more |
| Model numbers | TPL0059 |
Product
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3156-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.