HEALIX PEEK ORTHOCORDRecalls & reported problems across all models
Medos International Sàrl · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 278
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 6 models of HEALIX PEEK ORTHOCORD by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 278 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2017 and Jun 2, 2026 — classified as 13 injuries, 265 malfunctions.
The most frequently reported specific device problem is “Break” (223 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 PEEK ORTHOCORD problems
Device problems
- Break223
- Device-Device Incompatibility14
- Adverse Event Without Identified Device or Use Problem10
- Migration9
- Material Deformation8
- Device Damaged Prior to Use5
- Fracture5
- Crack4
Patient problems
- No Clinical Signs, Symptoms or Conditions145
- No Consequences Or Impact To Patient113
- Not Applicable7
- Fluid Discharge4
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient4
- Impaired Healing3
- Unspecified Infection3
HEALIX PEEK ORTHOCORD models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HEALIX PEEK ORTHOCORD 222205Screw, fixation, bone186 reports
- HEALIX PEEK ORTHOCORD 222207FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE42 reports
- HEALIX PEEK ORTHOCORD 222344Screw, fixation, bone24 reports
- HEALIX PEEK ORTHOCORD 222209Screw, fixation, bone23 reports
- HEALIX PEEK ORTHOCORD 222210FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- HEALIX PEEK ORTHOCORD 222219Screw, fixation, bone1 report
Recent HEALIX PEEK ORTHOCORD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED. 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 25363224 ↗MalfunctionMay 26, 2026Break
IT WAS REPORTED THAT DURING ACHILLES TENDON REPAIR SURGERY, THE HEALIX PEEK ORTHOCORD ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279344 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD ANCHOR DEVICE BROKE. ALL BROKEN PIECES WERE REMOVED. 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 24831022 ↗MalfunctionFeb 10, 2026Migration
IT WAS REPORTED THAT DURING THE SURGERY, THE 4.5 HEALIX PEEK ANCH.W/OCORD PULLED OUT MULTIPLE TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 5 MINUTE DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307786 ↗MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250180 ↗MalfunctionJan 22, 2026Break; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE WAS FRACTURED (BROKEN IN TWO PIECES). IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE SHAFT WAS BROKEN OFF WHILE STILL IN THE PACKAGE PRIOR TO A ROTATOR CUFF REPAIR PROCEDURE. ANOTHER 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 24144419 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT DURING AN ACHILLES REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908920 ↗MalfunctionSep 19, 2025Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23094735 ↗MalfunctionAug 19, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE THREADS PEELED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22839736 ↗MalfunctionAug 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS DEFORMED. THE ANCHOR WAS REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22818474 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809114 ↗MalfunctionJul 22, 2025Migration; Migration
IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS PULED OUT DURING INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565681 ↗MalfunctionJul 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A PATELLAR DISLOCATION PROCEDURE, IT WAS FOUND THAT THE THREAD OF THE ANCHOR ON THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE PEELED WHEN THE ANCHOR WAS INSERTED. THERE WAS FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 22540320 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507703 ↗MalfunctionJul 3, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR RECONSTRUCTION OF A PATELLAR LIGAMENT IN THE KNEE IT WAS OBSERVED THAT THE 4.5 HEALIX PEEK ANCH.W/OCORD DEVICE ANCHOR WAS BROKEN OFF AND THE SUTURE WAS BROKEN. ALL BROKEN PARTS WERE REMOVED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY WHEN IMPLANTED IN PATIENT, THE SUTURE WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395799 ↗
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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