HEALIX ADVANCE 222427Recalls & reported problems
Medos International Sàrl · HEALIX ADVANCE SP PEEK ANCHOR 6.5mm · Class 2 · Implant
All models of HEALIX ADVANCE (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705030613), received between Mar 10, 2023 and Feb 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Migration
IT WAS REPORTED THAT DURING AN UNKNOWN SHOULDER PROCEDURE, A 6.5MM HEALX ADV SP PEEK ANCHOR ANCHOR DEVICE WAS USED. THE BONE QUALITY WAS NOT GREAT, HOWEVER, HELIX MEDIAL ROW WAS FINE AND A COMPETITORS DEVICE WAS ALSO FINE. THE 6.5 ANCHOR PULLED OUT. FOUR SUTURES GOING THROUGH THE ANCHOR. THE STAY STITCH WAS RELEASED BUT THE SHAFT WOULD NOT COME UNDONE FROM THE ANCHOR. ACCORDING TO THE DOCTOR "THE FRICTION BETWEEN THE INSERTER AND THE ANCHOR IS SO TIGHT THAT WHEN PULLING THE INSERTER OUT THE ANCHOR CAME WITH IT". SURGEON HAD TO LEAVE THE ANCHOR PROUD AND USE THE SUTURES COMING OFF OF THE ANCHOR WITH A LATERAL ROW SWIVEL LOCK TO HOLD THE SUTURES AND OUR 6.5 ANCHOR DOWN. 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 24283718 ↗MalfunctionMar 10, 2023Migration; Migration
IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 6.5MM HEALX ADV SP PEEK ANCHOR DEVICE PULLED OUT AFTER BEING INSERTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16523615 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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