ORTHOCORD HEALIX BRRecalls & reported problems across all models
Medos International Sàrl · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 227
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 5 models of ORTHOCORD HEALIX BR by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 227 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2018 and Jan 27, 2026 — classified as 9 injuries, 218 malfunctions.
The most frequently reported specific device problem is “Break” (198 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 ORTHOCORD HEALIX BR problems
Device problems
- Break198
- Material Frayed8
- Material Split, Cut or Torn6
- Detachment of Device or Device Component3
- Device Damaged Prior to Use3
- Loose or Intermittent Connection3
- Adverse Event Without Identified Device or Use Problem2
- Crack2
Patient problems
- No Consequences Or Impact To Patient127
- No Clinical Signs, Symptoms or Conditions90
- Foreign Body In Patient6
- Not Applicable6
- No Known Impact Or Consequence To Patient4
- No Code Available3
- Injury2
- Fluid Discharge1
ORTHOCORD HEALIX BR models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ORTHOCORD HEALIX BR 222229FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE118 reports
- ORTHOCORD HEALIX BR 222233FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE66 reports
- ORTHOCORD HEALIX BR 222232FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE34 reports
- ORTHOCORD HEALIX BR 222238FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE7 reports
- ORTHOCORD HEALIX BR 222239FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
Recent ORTHOCORD HEALIX BR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR SURGERY, THE 4.5 HEALIX BR ANCHOR W/OCORD 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 24189287 ↗MalfunctionJul 17, 2025Break; Break
IT WAS REPORTED THAT DURING AN ACROMIOPLASTY AND LABRAL INJURY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE AT THE MOMENT OF IMPLANTATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO 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 22536407 ↗MalfunctionNov 19, 2024Break; Break
IT WAS REPORTED THAT DURING A LEFT ARTHROSCOPIC SHOULDER JOINT CLEANING SURGERY AND ROTATOR CUFF REPAIR SURGICAL PROCEDURE 2X 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER DEVICE AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724403 ↗MalfunctionNov 19, 2024Break; Break
IT WAS REPORTED THAT DURING A LEFT ARTHROSCOPIC SHOULDER JOINT CLEANING SURGERY AND ROTATOR CUFF REPAIR SURGICAL PROCEDURE 2X 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER DEVICE AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724239 ↗MalfunctionAug 26, 2024Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE HAD BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED, AND ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY. HOWEVER, THE SAME ISSUE OCCURRED WITH THE REPLACEMENT DEVICE. 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 WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20069729 ↗MalfunctionMay 22, 2024Break; Break
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372441 ↗MalfunctionMay 22, 2024Break; Break
IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19369701 ↗MalfunctionApr 25, 2024Break; Break
IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19184883 ↗MalfunctionApr 24, 2024Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4) . IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19176730 ↗MalfunctionApr 24, 2024Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19176722 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2 024, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19077810 ↗MalfunctionApr 4, 2024Break; Material Frayed; Device Damaged Prior to Use; Break; Material Frayed; Device Damaged Prior to Use
IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS BROKEN UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUTURE WAS FRAYED AND BROKEN ON THE DEVICE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042181 ↗MalfunctionApr 4, 2024Break; Break
REPORT 1 OF 2 FOR (B)(4) IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE 4.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039499 ↗MalfunctionApr 4, 2024Break; Break
REPORT 2 OF 2 FOR (B)(4) IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE 4.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039497 ↗MalfunctionApr 3, 2024Break; Break
IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 4.5 HEALIX BR ANCHOR W/OCORD DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19035765 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page