ICONIX 3910500322Recalls & reported problems
Stryker Corporation · ICONIX 2 TT WITH INTELLIBRAID TECHNOLOGY, 2.3MM ANCHOR WITH 2 STRANDS 2.0MM XBRAID TT · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327176933), received between May 8, 2019 and Mar 26, 2025 — classified as 8 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Expiration Date Error3
- Appropriate Device Problem Term/Code Not Available2
- Break2
- Contamination1
- Device Contaminated During Manufacture or Shipping1
- Entrapment of Device1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Foreign Body In Patient3
- No Code Available3
- Insufficient Information2
- Pain2
- Device Embedded In Tissue or Plaque1
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21702292 ↗MalfunctionMar 19, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647796 ↗InjuryMar 18, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT IN A QUAD TENDON REPAIR THE INSERTER OF AN ICONIX ANCHOR BROKE IN THE PATELLA AND THAT PIECE REMAINED IN THE PATELLA.
Patient problems: Foreign Body In Patient
MAUDE report 21638794 ↗InjuryAug 24, 2022Break
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15285431 ↗MalfunctionAug 24, 2021Contamination; Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12359666 ↗MalfunctionJul 28, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAD POST-OP PAIN RESULTING IN THE ANCHORS BEING REMOVED.
Patient problems: Pain
MAUDE report 12239057 ↗InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT HAD POST-OP PAIN RESULTING IN THE ANCHORS BEING REMOVED.
Patient problems: Pain
MAUDE report 12239052 ↗MalfunctionJun 29, 2021Break; Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12086483 ↗InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available
MAUDE report 10395751 ↗InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available
MAUDE report 10395750 ↗InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available
MAUDE report 10395747 ↗MalfunctionJun 17, 2019Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED
Patient problems: No Information
MAUDE report 8703895 ↗InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT UNINTENDED MATERIAL WAS LEFT IN THE JOINT.
Patient problems: Foreign Body In Patient
MAUDE report 8593064 ↗InjuryMay 8, 2019Entrapment of Device
IT WAS REPORTED THAT UNINTENDED MATERIAL WAS LEFT IN THE JOINT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8592854 ↗
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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