ICONIX 3910-500-532Recalls & reported problems
Stryker Corporation · 2.3MM ICONIX 3 ANCHOR W/INTELLIBRAID TECHNOLOGY 3 STRANDS #2 FORCE FIBER · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252450368), received between Jul 28, 2020 and Jun 11, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product2
- Appropriate Device Problem Term/Code Not Available1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Implant Pain1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Delivered as Unsterile Product
It was reported that when opening the package, it was noticed that one side of the packaging was not sealed, meaning the item was not sterile.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476784 ↗MalfunctionJun 11, 2026Delivered as Unsterile Product
It was reported that when opening the package, it was noticed that one side of the packaging was not sealed, meaning the item was not sterile.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476783 ↗InjuryJul 28, 2020Appropriate Device Problem Term/Code Not Available; Separation Problem; Separation Problem
IT WAS REPORTED THERE WAS A NEED FOR A REVISION SURGERY.
Patient problems: Implant Pain; No Known Impact Or Consequence To Patient
MAUDE report 10336208 ↗
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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