HEALIX ADVANCE BR ANCHOR w/DYNACORD 222011Recalls & reported problems
Medos International Sàrl · HEALIX ADVANCE BR ANCHOR w/DYNACORD TCP/PLGA Absorbable Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Metric) DYNACORD Suture, 36" (91cm) 6.5mm · Class 2 · Implant
All models of HEALIX ADVANCE BR ANCHOR w/DYNACORD (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705029525), received between Jun 12, 2023 and Jun 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (1 report).
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.
Most reported problems
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2023Migration; Migration
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) DEVICE HAD NO FIXATION AND PULLED OUT OF THE PATIENT'S BONE IMMEDIATELY. ACCORDING TO THE REPORT, THE PHYSICIAN UPSIZED TO A 6.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE AND WHITE/BLUE/GREEN) DEVICE BUT PULLED AS WELL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17110040 ↗
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
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 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
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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