RIGIDLOOPRecalls & reported problems across all models
Medos International Sàrl · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 831
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls
- 0
We found 16 models of RIGIDLOOP by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 831 adverse event reports in the FDA's MAUDE database, received between Jan 16, 2018 and Sep 29, 2026 — classified as 58 injuries, 773 malfunctions.
The most frequently reported specific device problem is “Break” (686 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 RIGIDLOOP problems
Device problems
- Break686
- Adverse Event Without Identified Device or Use Problem31
- Material Split, Cut or Torn29
- Material Frayed24
- Loosening of Implant Not Related to Bone-Ingrowth9
- Detachment of Device or Device Component8
- Material Deformation8
- Migration8
Patient problems
- No Clinical Signs, Symptoms or Conditions640
- No Consequences Or Impact To Patient93
- Not Applicable48
- Unspecified Tissue Injury33
- No Code Available8
- Tissue Damage7
- Discomfort4
- Foreign Body In Patient4
RIGIDLOOP models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RIGIDLOOP 232447FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- RIGIDLOOP 232448FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE96 reports
- RIGIDLOOP 232011FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE19 reports
- RIGIDLOOP 232009FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE18 reports
- RIGIDLOOP 232453INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT13 reports
- RIGIDLOOP 232460INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT11 reports
- RIGIDLOOP 232014FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE9 reports
- RIGIDLOOP 232025ORTHOPEDIC MANUAL SURGICAL INSTRUMENT8 reports
- RIGIDLOOP 232028ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- RIGIDLOOP 232037KIT, SURGICAL INSTRUMENT, DISPOSABLE6 reports
- RIGIDLOOP 232449FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE5 reports
- RIGIDLOOP 232034FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- RIGIDLOOP 218034ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- RIGIDLOOP 232018FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- RIGIDLOOP 232021FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- RIGIDLOOP 232030ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent RIGIDLOOP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938199 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938186 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937668 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937659 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937658 ↗MalfunctionSep 28, 2026Delivered as Unsterile Product; Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923036 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890315 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890304 ↗MalfunctionSep 21, 2026Break; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847261 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829231 ↗MalfunctionSep 17, 2026Device-Device Incompatibility
It was reported that during an arthroscopic anterior cruciate ligament repair procedure. the RGDLOOP ADJUSTABLE STND anchor device could not be deployed. 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 50804312 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793774 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788131 ↗MalfunctionSep 14, 2026Break
It was reported that during Shoulder clavicular joint dislocation surgery, when tightening the RIGIDLOOP suture device, the suture was broken off. Changed another one to continue the surgery, the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.Report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754500 ↗MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754499 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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