Mazor X SystemRecalls & reported problems across all models

We found 7 models of Mazor X System by Mazor Robotics Ltd in the FDA's device registry (GUDID). Together they are named in 847 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2017 and Sep 29, 2026 — classified as 4 deaths, 116 injuries, 727 malfunctions.

The most frequently reported specific device problem is “Imprecision” (354 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Mazor X System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 7 of these models · Recall details · FDA record ↗

2. Jul 17, 2024Open, Classified

   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.

   Z-3156-2024 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

3. Sep 5, 2023Open, Classified

   Software update

   Z-0101-2024 · Root cause: Software design · names 4 of these models · Recall details · FDA record ↗

Most reported Mazor X System problems

Mazor X System models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Mazor X System TPL0059-06

  Orthopedic Stereotaxic Instrument
  2 recalls2 deaths392 reports
• Mazor X System TPL0059-09

  Orthopedic Stereotaxic Instrument
  3 recalls1 death137 reports
• Mazor X System TPL0059-04

  Orthopedic Stereotaxic Instrument
  3 recalls1 death131 reports
• Mazor X System TPL0059-05

  Orthopedic Stereotaxic Instrument
  3 recalls65 reports
• Mazor X System TPL0059-08

  Orthopedic Stereotaxic Instrument
  1 recall110 reports
• Mazor X System TPL0059-07

  Orthopedic Stereotaxic Instrument
  2 recalls11 reports
• Mazor X System TPL0059-10

  Orthopedic Stereotaxic Instrument
  1 recall1 report

Recent Mazor X System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935938 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916343 ↗
• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905743 ↗
• MalfunctionMay 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A T9-L3 FUSION CASE, THE SCREWS ON T9 AND T10 WERE MEDIAL. THE SURGEON FREEHANDED THESE SCREWS. UNKNOWN HOW MANY MILLIMETERS (MM) THIS ALLEGED INACCURACY WAS. UNKNOWN IF THERE WAS A DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083968 ↗
• MalfunctionMay 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A L4-L5 ONE LEVEL CT-FLUORO CASE, THEY HAD DIFFICULTY REGISTERING WITH SINGLE-ARM RETRACTORS. SHE ATTEMPTED REGISTERING MULTIPLE LEVELS WITH NO RESOLUTION. THEY COMPLETED REGISTRATION BY REMOVING THE RETRACTORS. SHE STATED THE SCREENS HAD GONE BLACK. SYSTEM SOFT REBOOTED TO GET THE MONITORS BACK. SHE NOTED THERE WAS ALSO A SHOULDER SHIFT AFTER PLACING LEFT L4. WHEN THEY WENT TO PLACE RIGHT L4 SCREW, THEY NOTICED THE ARM WAS SHIFTED MEDIALLY, BUT THEY DID NOT PLACE THE SCREW. DOCTOR TRIED TO CORRECT THE ISSUE BY PHYSICALLY PUSHING THE ARM, RESULTING IN ANOTHER SHOULDER SHIFT. THERE WAS A 30 MINUTE DELAY. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A CONFIRMED INACCURACY AT RIGHT L4, ESTIMATED LESS THAN 3.5 MILLIMETERS (MM) INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071529 ↗
• InjuryApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE DRILL ITSELF. THE 3DEFINE, THE SNAPSHOT, AND THE FUSION OF THE FLUOROSCOPY IMAGES WITH THE PREOPERATIVE CT WAS CARRIED OUT AS USUAL. THE FUSION APPEARED ACCURATE, AND THEY PROCEEDED WITH THE SURGERY. THE SCREWS ON THE RIGHT SIDE WERE CORRECTLY PLACED, EXACTLY AS PLANNED USING THE NAVIGATION THAT ALSO APPEARED TO BE CORRECT. THE PROBLEM STARTED WITH THE LEFT SIDE. ALTHOUGH THE NAVIGATION STILL APPEARED TO BE CORRECT, WHEN THE DRILL WAS USED, THE PATIENT'S LEG SUDDENLY MOVED (JERKED), AND THE NEUROPHYSIOLOGIST OBSERVED THAT THE NERVE ROOT HAD BEEN AFFECTED. THEY RE-CHECKED THE SURGICAL PLAN AGAIN IN CASE THEY HAD MADE A MISTAKE, BUT IT WAS CORRECT. THE POTENTIALS OF THE LEFT L4 NERVE ROOT DROPPED BY MORE THAN 50 PERCENT WHEN THE DRILL WAS USED DURING THE SURGERY. WHEN THE PATIENT WOKE UP, NO NEUROLOGICAL DEFICITS WERE APPRECIATED. TWO DAYS AFTER, THE SURGEON CONFIRMED THAT THE PATIENT WAS OK. THE DELAY WAS MORE THAN 40 MINUTES.

  Patient problems: Dyskinesia; Unspecified Tissue Injury

  MAUDE report 24840917 ↗
• MalfunctionApr 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING CT-FLUORO CASE, AFTER REGISTRATION, MARKING OUT INCISIONS, THEY DID NOT MATCH THE PLAN. LEFT SIDE INCISIONS WERE MORE LATERAL (1/2 INCH) AND RIGHT SIDE INCISIONS WERE MORE MEDIAL (1/2 INCH) THAN PLAN. THEY RE-REGISTERED AND THEN THE NAVIGATION WAS ACCURATE. THERE WAS LESS THAN AN HOUR DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832092 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AT THE END OF A CASE AND CHECKING FOR ACCURACY, THE PELVIC SCREW WAS ALLEGEDLY INACCURATE. THEY RE-REGISTERED AND RESTARTED, ATTEMPTING TO PUT THE PELVIC SCREW IN AGAIN. THE PELVIC SCREW WAS MEDIAL COMPARED TO TRAJECTORY OF THE PLAN. THEY REMOVED THE SCREW COMPLETELY. THIS RESULTED IN 15 MINUTE DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713276 ↗
• MalfunctionMar 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ON 2026-MAR-18 (B)(4) (REP, HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE WORKFLOW WAS CT TO FLOURO WITH DOT REGISTRATION. L4 ON THE LEFT WAS INSERTED FIRST. HOWEVER, WHEN THE SURGEON MOVED TO L5 ON THE LEFT, HE FOUND THAT THE BONE WAS MORE DIFFICULT TO DRILL AND TAP. AFTER FEELING THAT THE TAP WAS NOT ADVANCING, THE SURGEON RE-DRILLED AND TAPPED AGAIN. IT DID NOT APPEAR TO BE DEVIATING AT THIS TIME. THE SCREW WAS INSERTED. THE SHOTS REVEALEDTHAT L5 SCREW WAS LATERAL ON THE LEFT. AROUND THAT TIME, THE PATIENT JUMPED WITH THE DRILL STILL INSIDE. THE SURGEON ELECTED TO SWITCH TO SCAN AND PLAN. THE IMAGING SYSTEM SCAN REVEALED THAT RIGHT L4 WAS BREACHED AS A RESULT OF THE PATIENT JUMPING. FOR SCAN AND PLAN, THE SURGEON DID NOT DISMOUNT FROM THE ORIGINAL MOUNT, BUT STILL STARTED FROM SCRATCH. L5 ON THE LEFT SCREW WAS INSERTED AGAIN. THE SURGEON THEN SWITCHED TO THE OTHER SIDE OF THE BED TO WORK ON L4. THE GUIDANCE SYSTEM ARM STAYED ON THE SAME SIDE. THE ARM WAS SENT TO L4 AND THE SCREW WAS INSERTED. WHEN THE SURGEON RE-EXAMINED L5, HE STATED THE SCREW FELT WEIRD, AS IF IT WASN'T IN ALL THE WAY. AN X-RAY W

  Patient problems: Dyskinesia

  MAUDE report 24651329 ↗
• MalfunctionMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A THORACIC FUSION T4-T10 CASE ON (B)(6) 2026, AFTER PLACING A SCREW, THEY BROUGHT IN X-RAY SYSTEM FOR DECOMPRESSION PURPOSES AND FOUND DEVIATED SCREW. THEY NOTICED THAT T4 ON THE LEFT LOOKED MEDIAL AND THE SURGEON IMMEDIATELY REMOVED THE SCREW. THEY ABORTED SYSTEM AND PROCEEDED WITH THE IMAGING SYSTEM AND NAVIGATION SYSTEM FOR THE CASE. THERE WAS LESS THAN AN HOUR DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590549 ↗
• MalfunctionMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING L4-L5 T RANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CT-FLOURO REGISTRATION, THE K-WIRE WAS MEDIAL IN THE PEDICLE OF L4 (RIGHT SIDE). THEY REGISTERED THE PATIENT AGAIN WHICH RESOLVED THE ISSUE. THERE WAS LESS THAN AN HOUR DELAY. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS WAS NOT A REGISTRATION ISSUE. THEY REGISTERED TO ENSURE ACCURACY MOVING FORWARD. IT WAS SUSPECTED THAT THE ANATOMY SHIFTED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535915 ↗
• MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A LATERAL SKIVE AND INACCURATE PLACEMENT OF A SCREW. SCREW WAS PLACED 3 MILLIMETERS (MM) INACCURATE IN LATERAL DIRECTION ON L5 VERTEBRAE RIGHT SIDE. AS A RESULT, SURGEON RE-PLACED THE SCREW WITHOUT NAVIGATION AND WAS THEN ACCURATE. SURGEON AND MANUFACTURING REPRESENTATIVE (REP) DISCUSSED FACET FUSION PRIOR TO SCREW PLACEMENT MAY HAVE DISRUPTED BONE, THEREFORE CAUSING ANATOMICAL SHIFT AND BEEN A POTENTIAL CAUSE FOR THE SKIVE. THERE WAS A 15 MINUTE DELAY. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498260 ↗
• InjuryFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Advance

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SCREWS WERE REMOVED AFTER THE FAULTY POSITION WAS SEEN INTRA-OPERATIVELY AND WERE NOT SEEN ON POST-OPERATIVE THREE-DIMENSIONAL (3D) SCANS. THE AMOUNT OF DEVIATION WAS ESTIMATED TO BE 10-15MM.

  Patient problems: Paralysis; Perforation

  MAUDE report 24474793 ↗
• MalfunctionFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO KNOWN IMPACT TO THE PATIENT. THE MANUFACTURING REPRESENTATIVE (REP) ALSO STATED THE DEVIATION AMOUNT WAS HARD TO SAY, BUT MAYBE 3.5 MILLIMETERS (MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470695 ↗
• 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 ↗

Other Mazor Robotics Ltd products

• Mazor X System- Refurbished2 models · 18 reports · 1 recall