Mazor X System TPL0059-10Recalls & reported problems
Mazor Robotics Ltd · Class 2
All models of Mazor X System (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290115751895), received between Feb 26, 2026 and Feb 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K230064, K251316); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Dec 10, 2025Open, Classified
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Z-1122-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ACCURACY ISSUE. INVOLVED REGIONS WERE NOTED TO BE THORACIC (T4 LEFT - ALL GOOD, T4 RIGHT - ALL GOOD, T5 LEFT - 2MM OFF PLAN MEDIAL AXIAL VIEW, T5 RIGHT - 3MM OFF PLAN AXIAL VIEW, T7 LEFT - 2MM OFF PLAN MEDIAL AXIAL VIEW, T7 RIGHT - 3MM OFF PLAN AXIAL VIEW, T8 LEFT - ALL GOOD, T8 RIGHT - ALL GOOD). THE CASE WAS COMPLETED WITH ROBOTICS. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461078 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K230064, K251316. One submission often covers many models, so check the product and lot details in each record.
- Z-3156-2024 · Jul 17, 2024 · Open, ClassifiedMazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Other Orthopedic Stereotaxic Instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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