ICONIX 3910-500-525Recalls & reported problems
Stryker Corporation · 2.3MM ICONIX 25 ANCHOR W/INTELLIBRAID TECHNOLOGY 2 STRANDS #5 FORCE FIBER · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252450351), received between Jun 20, 2022 and Jun 20, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS PATIENT INFECTION THAT REQUIRED A REVISION SURGERY. PLEASE NOTE IT IS CURRENTLY UNABLE TO BE CONFIRMED WHAT DEVICE CAUSED THE INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 14745848 ↗InjuryJun 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS PATIENT INFECTION THAT REQUIRED A REVISION SURGERY. PLEASE NOTE IT IS CURRENTLY UNABLE TO BE CONFIRMED WHAT DEVICE CAUSED THE INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 14744612 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- 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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