FMSRecalls & reported problems across all models
Medos International Sàrl · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,588
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls
- 0
We found 39 models of FMS by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 3,588 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2017 and Sep 28, 2026 — classified as 81 injuries, 3,507 malfunctions.
The most frequently reported specific device problem is “Break” (484 reports).
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
Most reported FMS problems
Device problems
- Break484
- Electrical Shorting476
- Use of Device Problem453
- Electrical /Electronic Property Problem375
- Device-Device Incompatibility305
- Overheating of Device243
- Output Problem204
- Detachment of Device or Device Component200
Patient problems
- No Clinical Signs, Symptoms or Conditions2,382
- No Consequences Or Impact To Patient959
- Not Applicable142
- Foreign Body In Patient72
- No Known Impact Or Consequence To Patient51
- No Patient Involvement15
- Extravasation9
- Unspecified Tissue Injury6
FMS models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FMS 283512ARTHROSCOPE1,800 reports
- FMS 283812Arthroscope374 reports
- FMS 284508ARTHROSCOPE304 reports
- FMS 283429ARTHROSCOPE138 reports
- FMS 283573ARTHROSCOPE133 reports
- FMS 282114ARTHROSCOPE123 reports
- FMS 281572Depressor, orbital103 reports
- FMS 283419ARTHROSCOPE93 reports
- FMS 283889ARTHROSCOPE75 reports
- FMS 283409ARTHROSCOPE47 reports
- FMS 283729ARTHROSCOPE41 reports
- FMS 283712Arthroscope39 reports
- FMS 281142ARTHROSCOPE38 reports
- FMS 283489ARTHROSCOPE34 reports
- FMS 284649ARTHROSCOPE34 reports
- FMS 283469ARTHROSCOPE28 reports
- FMS 284610ARTHROSCOPE20 reports
- FMS 283551ARTHROSCOPE19 reports
- FMS 283412Arthroscope17 reports
- FMS 283439ARTHROSCOPE16 reports
- FMS 283869ARTHROSCOPE14 reports
- FMS 283459ARTHROSCOPE14 reports
- FMS 283709ARTHROSCOPE12 reports
- FMS 283479ARTHROSCOPE8 reports
- FMS 283319ARTHROSCOPE8 reports
- FMS 283719ARTHROSCOPE7 reports
- FMS 283422Arthroscope7 reports
- FMS 281103ARTHROSCOPE6 reports
- FMS 283209ARTHROSCOPE6 reports
- FMS 283403Arthroscope5 reports
- FMS 283309ARTHROSCOPE5 reports
- FMS 283229ARTHROSCOPE4 reports
- FMS 281113ARTHROSCOPE3 reports
- FMS 283609ARTHROSCOPE3 reports
- FMS 283255Arthroscope2 reports
- FMS 283739ARTHROSCOPE2 reports
- FMS 283858ARTHROSCOPE2 reports
- FMS 283432Arthroscope2 reports
- FMS 283329ARTHROSCOPE2 reports
Recent FMS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Electrical /Electronic Property Problem
It was reported that during service and evaluation, it was determined that the SHAVER HANDPIECE 2.0 WITHOUT BUTTONS device had an electrical short. It was noted in the service order that the device displayed an FC05 and FC14 error code during a surgical procedure. 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 50914965 ↗MalfunctionSep 17, 2026Overheating of Device; Use of Device Problem
It was reported that during an unspecified arthroscopic procedure the SHAVER HANDPIECE 2.0 WITHOUT BUTTONS device became abnormal high temperature and stopped working.. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803828 ↗MalfunctionSep 17, 2026Break
It was reported that during an unknown surgery, the FMS device released metal debris from the Shaver blade. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802644 ↗MalfunctionSep 17, 2026Overheating of Device
It was reported that during Arthroscopic Rotator Cuff Repair surgery, while removing a subacromial osteophyte the SHAVER HANDPIECE 2.0 WITH BUTTONS used with the round burr plus 4.0mm produced a weaker-than-usual rotational sound and then rapidly became hot. The handpiece became too hot for the surgeon to hold. It was reported that there were no delays to the surgical procedure as a spare device was available to complete the surgery. 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 50802034 ↗MalfunctionSep 15, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779595 ↗MalfunctionSep 15, 2026Use of Device Problem; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779348 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777993 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776289 ↗MalfunctionSep 10, 2026Break; Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714010 ↗MalfunctionSep 3, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50593656 ↗MalfunctionSep 3, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591844 ↗MalfunctionSep 2, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570545 ↗MalfunctionSep 1, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546521 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component; Power Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545667 ↗MalfunctionAug 24, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416990 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 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
- GRYPHON ORTHOCORD6 models · 918 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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