HEALIX ADVANCE ORTHOCORDRecalls & reported problems across all models
Medos International Sàrl · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,311
- Deaths reported
- 0
- Injuries reported
- 113
- Recalls
- 0
We found 21 models of HEALIX ADVANCE ORTHOCORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 1,311 adverse event reports in the FDA's MAUDE database, received between Jul 5, 2017 and Sep 30, 2026 — classified as 113 injuries, 1,198 malfunctions.
The most frequently reported specific device problem is “Break” (989 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 HEALIX ADVANCE ORTHOCORD problems
Device problems
- Break989
- Crack59
- Adverse Event Without Identified Device or Use Problem58
- Migration52
- Detachment of Device or Device Component38
- Material Deformation25
- Fracture21
- Difficult to Advance16
Patient problems
- No Clinical Signs, Symptoms or Conditions898
- No Consequences Or Impact To Patient276
- Unspecified Tissue Injury52
- Not Applicable36
- Unspecified Infection30
- Foreign Body In Patient19
- Injury12
- No Code Available11
HEALIX ADVANCE ORTHOCORD models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HEALIX ADVANCE ORTHOCORD 222295FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALIX ADVANCE ORTHOCORD 222296FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- HEALIX ADVANCE ORTHOCORD 222298FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE116 reports
- HEALIX ADVANCE ORTHOCORD 222297FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE77 reports
- HEALIX ADVANCE ORTHOCORD 222303Screw, fixation, bone48 reports
- HEALIX ADVANCE ORTHOCORD 222304Screw, fixation, bone27 reports
- HEALIX ADVANCE ORTHOCORD 222299FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE21 reports
- HEALIX ADVANCE ORTHOCORD 222305Screw, fixation, bone15 reports
- HEALIX ADVANCE ORTHOCORD 222301FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE8 reports
- HEALIX ADVANCE ORTHOCORD 222307Screw, fixation, bone8 reports
- HEALIX ADVANCE ORTHOCORD 222308Screw, fixation, bone8 reports
- HEALIX ADVANCE ORTHOCORD 222320FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE6 reports
- HEALIX ADVANCE ORTHOCORD 222323FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE4 reports
- HEALIX ADVANCE ORTHOCORD 222300FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
- HEALIX ADVANCE ORTHOCORD 222311Screw, fixation, bone2 reports
- HEALIX ADVANCE ORTHOCORD 222319FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
- HEALIX ADVANCE ORTHOCORD 222325Screw, fixation, bone2 reports
- HEALIX ADVANCE ORTHOCORD 222302FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- HEALIX ADVANCE ORTHOCORD 222321Screw, fixation, bone1 report
- HEALIX ADVANCE ORTHOCORD 222322Screw, fixation, bone1 report
- HEALIX ADVANCE ORTHOCORD 222324FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
Recent HEALIX ADVANCE ORTHOCORD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951528 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949221 ↗MalfunctionSep 30, 2026Break
It was reported that during a Shoulder arthroscopy surgical procedure, when using the 4.5 HEALIX ADVANCE BR W/OCORD anchor device, it was observed that the anchor was broken off. It was reported that all broken parts were removed. It was reported that the surgeon changed to another 4.5 HEALIX ADVANCE BR W/OCORD anchor device and the same problem happened again. It was reported that another device was used to complete the procedure. There were no adverse consequences to the patient. No additional information could be provided.This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949216 ↗MalfunctionSep 30, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948980 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935717 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935712 ↗MalfunctionSep 29, 2026Material Deformation
It was reported that during an unknown surgery the shaft of the 4.5 HEALIX ADVANCE BR W/OCORD device was bent and deformed. It was reported that a spare device was used 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 50933813 ↗MalfunctionSep 29, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933489 ↗MalfunctionSep 29, 2026Migration
This is report 2 of 2 for (b)(4)It was reported that during a Rotator Cuff Repair procedure, it was discovered that the anchor on the 4.5 HEALIX ADVANCE PEEK W/CORD device pulled out. A replacement device was used to continue the surgery, but the same issue occurred again. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used 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 50933487 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933360 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931971 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931969 ↗MalfunctionSep 29, 2026Break
This is report 5 of 5 for (b)(4).It was reported that during an Anterior Cruciate Ligament Reconstruction surgery, four anchors on the 4.75 HEALIX ADVANCE KNTLSS BR devices and one screw on the INTRAFX ADVBR SCW7X23 W/SMSHTH device broke off. All the broken parts were removed. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used 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 50931968 ↗MalfunctionSep 29, 2026Break
It was reported that during an unspecified surgery, the HEALIX ADVANCE ORTHOCORD anchor was broken. All the broken parts were removed. Changed to another two HEALIX ADVANCE ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929781 ↗MalfunctionSep 29, 2026Break
It was reported that during an unspecified surgery, the HEALIX ADVANCE ORTHOCORD anchor was broken. All the broken parts were removed. Changed to another two HEALIX ADVANCE ORTHOCORDs to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929778 ↗
Other Medos International Sàrl products
All Medos International Sàrl 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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