ICONIX 3910500920Recalls & reported problems
Stryker Corporation · ICONIX SPEED ANCHOR 2.3MM 2 STRANDS 2.0MM XBRAID TT SUTURE TAPE · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327374193), received between Dec 16, 2020 and Apr 20, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Patient Device Interaction Problem2
- Device Contaminated During Manufacture or Shipping1
- Expiration Date Error1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Unspecified Infection2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A FOREIGN MATERIAL (SUSPECTED TO BE HAIR) WAS FOUND INSIDE A STERILIZED POUCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932502 ↗InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THERE ARE TWO PATIENTS WITH INFECTION AFTER INSERTION OF THE OMEGA + SPEED ANCHOR.
Patient problems: Unspecified Infection
MAUDE report 18784640 ↗InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THERE ARE TWO PATIENTS WITH INFECTION AFTER INSERTION OF THE OMEGA + SPEED ANCHOR.
Patient problems: Unspecified Infection
MAUDE report 18778485 ↗MalfunctionDec 8, 2023Product Quality Problem; Expiration Date Error; Product Quality Problem; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18297300 ↗InjuryDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ANCHORS DETACHED AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11016362 ↗InjuryDec 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ANCHORS DETACHED AND REMAINED IN THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11016061 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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