Mazor X robotic guidance system REF: TPL0059 — Class II medical device recall Z-1122-2026
Ongoing recall by Mazor Robotics Ltd, reported 2026-01-28, distributed nationwide. Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
| Recall number | Z-1122-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mazor Robotics Ltd, Caesarea, Israel |
| Recall initiated | 2025-12-10 |
| Classified | 2026-01-16 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CN, DE, ES, FR, GB, GR, HK, HR, HU, IL, IN, IT, JP, MX, MY, NL, PL, PT, RO, SE, SG, SK, TH, TR, TW, UA, VN |
| Quantity | 549 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000419134, 00763000431761, 00763000635169, 07290109180465, 07290109181158, 07290109183213, 07290109184098, 07290109184517, 07290109184524, 07290109184838, 07290115751376, 07290115751895 |
| Model numbers | TPL0059 |
Product
Mazor X robotic guidance system REF: TPL0059
Reason for recall
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
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-1122-2026. 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.