ORTHOCORD HEALIX TI 222248Recalls & reported problems
Medos International Sàrl · HEALIX Ti Anchor w/ORTHOCORD and Needles Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) with MO-7 tapered needles 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705007943), received between Aug 9, 2019 and Aug 9, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2019Failure to Advance; Failure to Advance
IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE HEALIX TI ANCHOR COULD NOT BE FIXED. NO HARM TO PATIENT; NO DELAY IN SURGERY. SURGERY COMPLETED WITH NEW DEVICE. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED: IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE HEALIX TI ANCHOR COULD NOT BE FIXED. NO HARM TO PATIENT; NO DELAY IN SURGERY. SURGERY COMPLETED WITH NEW DEVICE.THE PROCEDURE INVOLVED IS A SHOULDER ROTATOR CUFF. THERE WAS NO DIFFICULTY ALIGNING INSTRUMENTS REQUIRED FOR INSERTION PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE NEEDED TO INSERT THE DEVICE. THE PATIENT¿S BONE QUALITY IS NORMAL WETHER TO HARD NOR TO SOFT. THE SURGEON IS A VERY EXPERIENCED USER WHO PLACED A HUGE NUMBER OF HEALIX ANCHORS. THE SURGEON USED SAME BONE HOLE TO COMPLETE THE PROCEDURE. THERE WAS NO DEBRIS LEFT IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8880330 ↗
Other STAPLE, FIXATION, BONE devices
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- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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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