HEALIX Ti DYNATAPE 280813Recalls & reported problems
Medos International Sàrl · HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) Black/Blue 2.5mm DYNATAPE Suture (1) White/Blue/Green, Size 2 (5 Metric), DYNACORD Suture, 36 inch (91 cm) BLACK 4.5mm · Class 2 · Implant
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 10886705031122), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
- Material Deformation1
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 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE GRYPHON P BR DS ANCHOR W/OC DEVICE, AFTER INSERTING THE IMPLANT, THE SUTURE DID NOT COME OUT SMOOTHLY FROM THE SHAFT, SO WHEN THE SURGEON PULLED IT OUT WITH FORCE, THE IMPLANT CAME OUT WITH IT, AND SLIGHT DAMAGE WAS FOUND AT THE TIP. A NEW PRODUCT WAS OPENED AND USED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143391 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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