ICONIX 3910500931Recalls & reported problems
Stryker Corporation · ICONIX SPEED Anchor 2.3mm 3 Strands 1.2mm XBraid TT Suture Tape · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327374223), received between Mar 23, 2021 and Oct 11, 2023 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (4 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
- Premature Separation4
- Break3
Patient problems
- Pain4
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING ABOUT POST-OPERATIVE PAIN. A FOLLOW-UP REVISION SURGERY WAS PERFORMED AND IT WAS FURTHER REPORTED THAT THE ANCHORS HAD RUPTURED.
Patient problems: Pain
MAUDE report 17916514 ↗InjuryOct 11, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING ABOUT POST-OPERATIVE PAIN. A FOLLOW-UP REVISION SURGERY WAS PERFORMED AND IT WAS FURTHER REPORTED THAT THE ANCHORS HAD RUPTURED.
Patient problems: Pain
MAUDE report 17916510 ↗InjuryOct 11, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING ABOUT POST-OPERATIVE PAIN. A FOLLOW-UP REVISION SURGERY WAS PERFORMED AND IT WAS FURTHER REPORTED THAT THE ANCHORS HAD RUPTURED.
Patient problems: Pain
MAUDE report 17913964 ↗InjuryOct 11, 2023Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING ABOUT POST-OPERATIVE PAIN. A FOLLOW-UP REVISION SURGERY WAS PERFORMED AND IT WAS FURTHER REPORTED THAT THE ANCHORS HAD RUPTURED.
Patient problems: Pain
MAUDE report 17913956 ↗InjuryJul 25, 2022Break
IT WAS REPORTED THAT THE INSERTER TIP BROKE AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15095249 ↗MalfunctionApr 28, 2021Break
IT WAS REPORTED THAT THE INSERTER TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11737211 ↗InjuryMar 23, 2021Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. IT COULD NOT BE CONFIRMED IF IT WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11555680 ↗
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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