ICONIX 3910500312Recalls & reported problems
Stryker Corporation · ICONIX 1 TT WITH INTELLIBRAID TECHNOLOGY, 1.4MM ANCHOR WITH 1 STRAND 1.2MM XBRAID TT · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327176926), received between Jul 30, 2018 and Apr 26, 2023 — classified as 5 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Material Fragmentation2
- Contamination1
- Contamination /Decontamination Problem1
- Device Markings/Labelling Problem1
- Entrapment of Device1
- Expiration Date Error1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Foreign Body In Patient5
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED, THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820035 ↗MalfunctionSep 19, 2022Break
IT WAS REPORTED THAT THE INSERTER BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15448446 ↗InjuryJun 13, 2022Break
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE AND REMAINED IN THE BONE OF THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 14678764 ↗MalfunctionNov 18, 2021Contamination; Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12838027 ↗InjuryApr 28, 2021Break; Material Fragmentation; Material Fragmentation
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 11737212 ↗InjuryMar 16, 2021Break; Entrapment of Device
IT WAS REPORTED THAT THE FORK ON THE INSERTER BROKE AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11496037 ↗InjuryJan 21, 2021Break
IT WAS REPORTED THAT THE FORK ON THE INSERTER BROKE AND REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11207556 ↗MalfunctionOct 23, 2020Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE INSERTER OF THE DEVICE IS POTENTIALLY WHAT BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10731147 ↗MalfunctionSep 28, 2020Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10597299 ↗InjuryJul 30, 2018Break
IT WAS REPORTED THAT THE PRODUCT BROKE. THE BROKEN PIECE REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 7733057 ↗
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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