VELYSRecalls & reported problems across all models
Depuy (Ireland) · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,962
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 1
We found 15 models of VELYS by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 1,962 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2020 and Sep 29, 2026 — classified as 15 injuries, 1,947 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (1,210 reports).
1 FDA recall record name at least one of these models by its device identifier.
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.
- Mar 11, 2022Class IITerminated
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
Z-1029-2022 · Root cause: Software design · Recall details · FDA record ↗
Most reported VELYS problems
Device problems
- Device Slipped1,210
- Malposition of Device246
- Device-Device Incompatibility127
- Premature Separation101
- Leak/Splash86
- Positioning Problem77
- Appropriate Device Problem Term/Code Not Available67
- Mechanical Problem64
Patient problems
- No Clinical Signs, Symptoms or Conditions1,701
- Unspecified Tissue Injury171
- Bone Notching96
- Limb Fracture5
- Insufficient Information4
- Osteopenia/ Osteoporosis2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
VELYS models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VELYS 4515-70-105Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Orthopedic stereotaxic instrument564 reports
- VELYS 4515-70-101Orthopedic stereotaxic instrument324 reports
- VELYS 4515-70-102Orthopedic stereotaxic instrument263 reports
- VELYS 4515-70-107Orthopedic stereotaxic instrument144 reports
- VELYS 4515-70-100Orthopedic stereotaxic instrument1 recall10 reports
- VELYS 4515-70-109Orthopedic stereotaxic instrument26 reports
- VELYS 4515-70-000Orthopedic stereotaxic instrument25 reports
- VELYS 4515-70-001Orthopedic stereotaxic instrument14 reports
- VELYS 451580051System, image processing, radiological5 reports
- VELYS 4515-70-005ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- VELYS 451580052Neurological stereotaxic Instrument3 reports
- VELYS 4515-70-006ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- VELYS 4515-70-108ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- VELYS 4515-70-013Orthopedic 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: Bone Notching
MAUDE report 50937326 ↗MalfunctionSep 29, 2026Use of Device Problem; Malposition of Device
Patient problems: Bone Notching
MAUDE report 50937053 ↗MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method; Malposition of Device
Patient problems: Bone Notching
MAUDE report 50913935 ↗MalfunctionSep 28, 2026Device Slipped
It was reported that during sterile processing it was observed that 2x Robotic Assisted Saw Interface Device (SASI) Right devices were loose. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.This is report 2 of 2 for(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913752 ↗MalfunctionSep 28, 2026Device Slipped
It was reported that during sterile processing it was observed that 2x Robotic Assisted Saw Interface Device (SASI) Right devices were loose. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913751 ↗MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method; Malposition of Device
It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, when using the Robotic Assisted Satellite Station Device and the Robotic Assisted Base Station Device it was observed that the flexion gaps (medial distal condyle) was not lining up with what the surgeon was seeing and feeling in the patient anatomy. After re-registering, they went back into the Accubalance graph, went through the range of motion with the knee, and the flexion gaps increased medially and laterally. They went through the range of motion three more times, and the surgeon was still not seeing satisfactory measurements. They then re-registered points, remeasured the center of the tibia, posterior/distal condyle, and anterior aspect of femur. The surgeon then proceeded back to the Accubalance graph and was able to get measurements that lined up with the patient¿s anatomy. After this, they moved forward to resections and made them with machine size 9 settings, but they noticed the trial did not meet resections. It was reported that the Size 9 was much larger than the resections. The surgeon then chose the size 8 trial for a better fit. The Posterior chamfer was too deep however, and the patie
Patient problems: Bone Notching
MAUDE report 50913635 ↗MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method; Malposition of Device
It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, when using the Robotic Assisted Satellite Station Device and the Robotic Assisted Base Station Device it was observed that the TKA cuts were not hitting the mark. It was reported that the accuracy and resections were not what the surgeon wanted. It was reported that the robot was not mounted to the surgical bed. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.
Patient problems: Bone Notching
MAUDE report 50913532 ↗MalfunctionSep 25, 2026Improper or Incorrect Procedure or Method; Malposition of Device
Patient problems: Bone Notching
MAUDE report 50903250 ↗MalfunctionSep 25, 2026Improper or Incorrect Procedure or Method; Malposition of Device
Patient problems: Bone Notching
MAUDE report 50903148 ↗MalfunctionSep 25, 2026Improper or Incorrect Procedure or Method; Malposition of Device
Patient problems: Bone Notching
MAUDE report 50902476 ↗MalfunctionSep 25, 2026Leak/Splash
It was reported that during set up for a Total Knee Arthroplasty (TKA) surgery, the Robotic-Assisted Solution Saw Handpiece was leaking oil. A different saw handpiece was used during the surgery. Patient treatments were not delayed or cancelled. There was no patient involvement. The device was operated in conjunction with the Robotic-Assisted Solution Base Station device and the Robotic-Assisted Solution Satellite Station device. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901441 ↗MalfunctionSep 25, 2026Device Slipped
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900824 ↗MalfunctionSep 23, 2026Device Slipped; Device-Device Incompatibility
It was reported that during a Total Knee Arthroplasty (TKA), the VELYS Array Interface device was not tightening in the middle and could be pulled out easily. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868048 ↗MalfunctionSep 23, 2026Device Slipped
It was reported that during setup and registration of the Robotic Assisted Saw Interface Device (SASI) Right device for a Total Knee Arthroplasty (TKA) surgical procedure it was reported that the SASI was loose and received an Error on the Robotic Assisted Base Station Device: unable to connect to the Robotic Assisted Saw Handpiece Device. It was further observed that the SASI wash caps were worn and did not properly fit on the SASI while washing. It was reported that a different SASI was used to resolve the connection issue. It was not reported if the robot was mounted to the surgical bed. It was reported that there was a 10-minute delay in the procedure due to the event. There was no patient involvement. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867156 ↗MalfunctionSep 22, 2026Failure to Cut
It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, it was observed that the Robotic Assisted Saw Handpiece Device would register but when in position to cut there was no power and VELYS SAW BLADE would not move. It was confirmed that the light was green, but the saw would still not move. It was reported that a new tray was opened and a new saw was used. It is unknown of the robot was mounted to the surgical bed. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853123 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →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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