MAZOR X robotic guidance system — Class II medical device recall Z-0101-2024
Ongoing recall by Mazor Robotics Ltd, reported 2023-10-18, distributed nationwide. Software update
| Recall number | Z-0101-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mazor Robotics Ltd, Caesarea, N/A, Israel |
| Recall initiated | 2023-09-05 |
| Classified | 2023-10-12 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 324 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07290109180465, 07290109181158, 07290109183213, 07290115751376 |
| Serial numbers | 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 and 291 more |
| Model numbers | TPL0059 |
Product
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Reason for recall
Software update
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-0101-2024. 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.