HEALIX ADVANCE ORTHOCORD 222295Recalls & reported problems
Medos International Sàrl · HEALIX ADVANCE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 4.5mm · Class 2 · Implant
All models of HEALIX ADVANCE ORTHOCORD (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medos Healix Advance anchor is an absorbable suture anchor used to fix soft tissue during surgery. Of the 600 reports naming it, most describe the anchor or its suture breaking during surgery, sometimes pulling out, and surgeons switching to another device. The reports include 11 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 640
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 640 adverse event reports that list this exact device (DI 10886705021314), received between Mar 16, 2018 and Sep 30, 2026 — classified as 11 injuries, 629 malfunctions.
The most frequently reported specific device problem is “Break” (581 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break581
- Migration23
- Detachment of Device or Device Component15
- Material Deformation13
- Crack10
- Device Damaged Prior to Use8
- Adverse Event Without Identified Device or Use Problem3
- Device-Device Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions579
- No Consequences Or Impact To Patient42
- Not Applicable10
- Foreign Body In Patient5
- Unspecified Tissue Injury4
- Injury2
- No Known Impact Or Consequence To Patient2
- Purulent Discharge2
Recent adverse event reports
The 25 most recent of 640 reports, 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, 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 ↗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 3 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929777 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923239 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923186 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916328 ↗MalfunctionSep 25, 2026Break
It was reported that during a rotator cuff repair 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 pieces were retrieved. It was reported that the surgeon changed to another 4.5 HEALIX ADVANCE BR W/OCORD anchor device to continue the procedure, and the same problem happened again. It was reported that the surgeon changed to another device to complete the procedure. There were no adverse consequences to the patient. No additional information could be provided.This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897610 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897605 ↗MalfunctionSep 23, 2026Break
It was reported that during an arthroscopic rotator cuff repair procedure the 4.5 HEALIX ADVANCE BR W/OCORD anchor device broke. All broken parts were removed. Changed another one to continue the surgery, the same problem happened again. 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. This is report 2 of 2 for(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870816 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870813 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867683 ↗MalfunctionSep 23, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another three 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 4 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867679 ↗MalfunctionSep 23, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another three 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 4 of 4 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867661 ↗MalfunctionSep 23, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD anchor was broken off. All the broken parts were removed. Changed to another HEALIX ADVANCE ORTHOCORD 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 was provided.This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865961 ↗
Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
- Arthrex® AR-1927BCF-45Arthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE164 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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