ORTHOCORD HEALIX TI 222241Recalls & reported problems
Medos International Sàrl · HEALIX Ti 3-Suture Anchor w/ORTHOCORD Titanium Anchor (1) Violet (1) Blue Strand, (1) Blue Striped, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 6.5mm · Class 2 · Implant
All models of ORTHOCORD HEALIX TI (6)
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 10886705007875), received between Nov 3, 2020 and Nov 3, 2020 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YAMAKADO, K, ET AL (2019) A PROSPECTIVE RANDOMIZED TRIAL COMPARING SUTURE BRIDGE AND MEDIALLY BASED SINGLE-ROW ROTATOR CUFF REPAIR IN MEDIUM-SIZED SUPRASPINATUS TEARS. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, VOL. 35, PAGES 2803-2813. (USA). THE STUDY EMPHASIZES ON THE COMPARISON OF THE CLINICAL AND IMAGING OUTCOMES BETWEEN THE SUTURE BRIDGE TECHNIQUE (SB) AND THE MEDIALLY BASED SINGLE-ROW TECHNIQUE (MEDSR) IN PATIENTS WITH 1- TO 3-CM TEAR SIZES. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: 166 PATIENTS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ALL PATIENTS WERE EVALUATED PREOPERATIVELY AND POSTOPERATIVELY (AT 12 AND 24 MONTHS) USING THE MODIFIED UNIVERSITY OF CALIFORNIA, LOS ANGELES SCORING SYSTEM; ACTIVE RANGE OF MOTION (FLEXION AND EXTERNAL ROTATION); AND A VISUAL ANALOG SCALE FOR PAIN. HEALING STATUS WAS EXAMINED BY POSTOPERATIVE MAGNETIC RESONANCE IMAGING. THE DEVICES INVOLVED WERE: HEALIX.
Patient problems: No Code Available; Tissue Damage
MAUDE report 10778004 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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