VELYSRecalls & reported problems across all models
Medos International Sàrl · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one VELYS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 4 models of VELYS by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Aug 4, 2025 and Sep 29, 2026 — classified as 3 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (24 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Reports received per month, all models
VELYS 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.
- Jul 23, 2026Class IIOpen, Classified
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Z-3088-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported VELYS problems
Device problems
- Malposition of Device24
- Positioning Failure14
- Use of Device Problem7
- Unintended System Motion5
- Break2
- Delivered as Unsterile Product2
- No Apparent Adverse Event2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Insufficient Information3
- Nerve Damage2
- Unspecified Infection1
VELYS models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VELYS 451611000Orthopedic stereotaxic instrument1 recall25 reports
- VELYS 451611001Orthopedic stereotaxic instrument21 reports
- VELYS 451611021Orthopedic stereotaxic instrument3 reports
- VELYS 451611002Orthopedic stereotaxic instrument1 report
Recent VELYS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933130 ↗MalfunctionSep 29, 2026Positioning Failure; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931541 ↗MalfunctionSep 16, 2026Mechanical Problem; Intermittent Loss of Power
It was reported that there was an excessive amount of joints clicking through out the case that resulted in temporary arm delays. Robot on Patient right. There were no reports of injuries, medical intervention or prolonged hospitalization. No further information was provided
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791620 ↗MalfunctionAug 17, 2026Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287454 ↗MalfunctionAug 17, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50274134 ↗MalfunctionMar 17, 2026Malposition of Device
IT WAS REPORTED THAT DURING AN OPEN LUMBAR PROCEDURE, THE DOCTOR WAS USING VERSE. FINAL PLACEMENT OF SCREWS WAS HIGHER THAN WHAT WAS ON THE NAV SCREEN. SURGEON BELIEVES THERE WAS A SHIFT THAT CAUSED THE PLACEMENT TO BE MOVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO PATIENT TREATMENTS WERE DELAYED OR CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619887 ↗MalfunctionMar 17, 2026Malposition of Device
DURING A MIS LUMBAR PROCEDURE, THE DOCTOR WAS USING VIPER PRIME AND NOTICED FINAL PLACEMENT OF SCREWS WAS HIGHER THAN ON THE NAV PLAN BY 2 MM AND CAUSED THE SURGEON TO FIX THE PLACEMENT ON TWO OF THE SCREWS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO TREATMENTS WERE DELAYED OR CANCELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617195 ↗MalfunctionMar 16, 2026Use of Device Problem; Malposition of Device
IT WAS REPORTED AN ISSUE OF THE L-4 (RIGHT SIDE) SCREW'S TRAJECTORY BEING UNREACHABLE OCCURRED DURING A L3-L5 SPINAL FUSION. THE SYSTEM DID NOT GIVE ANY ADVANCE WARNING. EVENT OCCURRED WHILE PLACING SCREWS WHILE ROBOT WAS ON PATIENT'S RIGHT SIDE. SURGEON ELECTED TO GO WITH FREE HAND FOR THAT SCREW NEXT DAY OF SURGERY: (B)(6) 2026. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605501 ↗MalfunctionMar 12, 2026Positioning Failure
IT WAS REPORTED THAT VELYS NAVIGATION STATION, VELYS ROBOTIC-ASSIST STATION, VELYS CAMERA STATION, AND VELYS SPINE ARRAY BASE SET WERE INVOLVED IN A REPORTED EVENT DURING A SPINAL PROCEDURE. THE ISSUE WAS DESCRIBED AS TWO SCREWS BEING PLACED 5MM OFF FROM THE PLANNED POSITION, WITH THE ROBOTIC SYSTEM POSITIONED ON THE PATIENT'S RIGHT SIDE. TROUBLESHOOTING INCLUDED CONDUCTING A SECOND SPIN BEFORE REMOVING AND REPLACING THE SCREWS. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586201 ↗MalfunctionMar 12, 2026Malposition of Device
IT WAS REPORTED THAT VELYS NAVIGATION STATION, VELYS ROBOTIC-ASSIST STATION, VELYS CAMERA STATION, AND VELYS SPINE ARRAY BASE SET WERE INVOLVED IN A REPORTED EVENT DURING A SPINAL PROCEDURE. THE ISSUE WAS DESCRIBED AS TWO SCREWS BEING PLACED 5MM OFF FROM THE PLANNED POSITION, WITH THE ROBOTIC SYSTEM POSITIONED ON THE PATIENT'S RIGHT SIDE. TROUBLESHOOTING INCLUDED CONDUCTING A SECOND SPIN BEFORE REMOVING AND REPLACING THE SCREWS. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578510 ↗MalfunctionFeb 27, 2026Delivered as Unsterile Product
RECEIVED WITH TAMPER PROOF SEAL COMPLETELY OPEN. NO CASES IMPACTED, PRODUCT WAS ORDERED FOR INTERNAL R&D TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469712 ↗MalfunctionFeb 27, 2026Delivered as Unsterile Product
RECEIVED WITH TAMPER PROOF SEAL COMPLETELY OPEN. NO CASES IMPACTED, PRODUCT WAS ORDERED FOR INTERNAL R&D TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469704 ↗MalfunctionFeb 20, 2026Break; Complete Loss of Power
IT WAS REPORTED THE ROBOT STATION'S TOUCHSCREEN POWER CABLE HAS EXPOSED WIRES AND ROBOT STATION WILL NOT POWER ON. CASE WAS COMPLETED AS NAV ONLY. NO FURTHER INFORMATION IS AVAILABLE. FACILITY HAS MULTIPLE NAV AND CAMERA STATIONS AND 1 ROBOT STATION. UNKNOWN WHICH NAV AND CAMERA STATIONS WERE BEING USED DURING THE CASE. THERE WERE NO TREATMENT DELAYS OR CANCELLATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401503 ↗MalfunctionFeb 17, 2026Positioning Failure
IT WAS REPORTED DURING A L4- S1 ROBOTIC ENABLED FUSION USING VIPER PRIME THE RIGHT L4 ANTICIPATED THAT SCREW WAS OFF DUE TO FEEDBACK FROM ROBOT. THIS WAS PATIENTS RIGHT SIDE. XRAY CONFIRMED THE SCREW WAS OFF. TO RECONCILE, THE SCREW WAS PLACED WITH FREEHAND NAVIGATION INTO THE CORRECT POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370065 ↗MalfunctionFeb 9, 2026No Apparent Adverse Event
IT WAS REPORTED THAT DURING A T4 TO L1 POSTERIOR SPINAL FUSION PROCEDURE, DURING SCREW THE SURGEON DEEMED THAT THE PHANTOM WAS INACCURATE WHEN T7 AND T8 ON THE LEFT SIDE WERE LATERAL TO PLAN. A SECOND SPIN WAS COMPLETED AND WHEN THEY PLACED THE REST OF THE SCREWS IN THE SEGMENT, 4 OF THE SCREWS WERE CONSIDERED INACCURATE TO PLAN: T6 WAS LATERAL ON LEFT SIDE, T5 ON THE RIGHT SIDE WAS DEEMED MEDIAL, T7 ON RIGHT SIDE WAS DEEMED MEDIAL AND T8 ON THE RIGHT SIDE WAS DEEMED MEDIAL. SOME SCREWS WERE REPLACED WITH FREE HAND NAVIGATION AND OTHERS WERE NOT IN THE SPIN WERE COMPLETED FREE HAND WITHOUT NAVIGATION. ROBOT WAS ON THE PATIENT'S RIGHT SIDE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292112 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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