HEALIX ADVANCE ORTHOCORD 222324Recalls & reported problems
Medos International Sàrl · HEALIX ADVANCE BR MULTIPACK - 3 SUTURE (5) TCP/PLGA Absorbable Anchors, Each Anchor contains (1) Violet (1) Blue Strand (1) Blue Striped, Size 2 (5 Metric) ORTHOCORD Braided Composite Suture, 36 Inches (91cm) 5.5mm · Class 2 · Implant
All models of HEALIX ADVANCE ORTHOCORD (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705021529), received between Jul 30, 2026 and Jul 30, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
Post Market Complication received for Re-Tears or new tears. Patient ID: (b)(6).It was reported that the patient underwent a right rotator cuff repair surgical procedure on (b)(6) 2025. It was reported that a 5.5 HEALIXADV BR 5PK-3SUTURE device, and the FMS VUE II system and VAPR system were used in the procedure. It was reported that the patient suffered re-tears/new tears of the rotator cuff on (b)(6) 2026. It was reported that the patient underwent revision of the rotator cuff on an unknown date. All available information has been disclosed. No additional information could be provided.
Patient problems: Unspecified Tissue Injury
MAUDE report 50082741 ↗
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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