Iconix 3911-523-731Recalls & reported problems
Riverpoint Medical, LLC · Iconix 2 TT, 2.3mm Anchor with 1 Strand Fixed Swaged 2.2mm XBraid TT (Black/White) and 1 Strand 1.2mm XBraid TT (White/Black) · Class 2 · Implant
All models of Iconix (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812444029895), received between Sep 24, 2025 and Oct 22, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).
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
- Material Integrity Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE REPORTER, "WHILE USING THE ICONIX 2TT SWAGED WITH THE BLACK AND WHITE SUTURE, THE SUTURE GOT SUPER FRAYED AND THE SWAGED ASPECT OF THE ANCHOR SEPARATED. THIS IS THE THIRD TIME I'VE BEEN IN A CASE WITH THIS ISSUE. WE SWITCHED TO THE BLUE ANCHOR AND IT WORKED FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358879 ↗MalfunctionOct 21, 2025Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE REPORTER, "WE WERE IN A CASE. WE IMPLANTED THE BLACK 2TT SWAGED ANCHOR. THE STRANDS GOT SUPER FRAYED ON INSERTION AND WE HAD TO PULL OUT THE ITEM AND TRY ANOTHER ONE. THE SWAGED ASPECT DIDN'T WORK ON THE SECOND ANCHOR EITHER. HE HAD TO MAKE A SECOND HOLE, SLOW DOWN HIS TIME.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353662 ↗MalfunctionSep 24, 2025Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE REPORTER, "WHILE USING THE ICONIX 2TT SWAGED WITH THE BLACK AND WHITE SUTURE, THE SUTURE GOT SUPER FRAYED AND THE SWAGED ASPECT OF THE ANCHOR SEPARATED. THIS IS THE THIRD TIME I'VE BEEN IN A CASE WITH THIS ISSUE. WE SWITCHED TO THE BLUE ANCHOR AND IT WORKED FINE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23137760 ↗
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- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
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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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