ICONIX 3910500922Recalls & reported problems
Stryker Corporation · ICONIX SPEED Anchor 2.3mm 2 Strands #2 Force Fiber Suture · Class 2 · Implant
All models of ICONIX (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327374209), received between Feb 26, 2020 and Aug 27, 2024 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture2
- Patient Device Interaction Problem2
- Expiration Date Error1
- Nonstandard Device1
Patient problems
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient2
- Unspecified Infection2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2024Fracture; Fracture
IT WAS REPORTED THAT POSTOPERATIVE X-RAYS SHOWED A METAL FRAGMENT, SUGGESTING THAT ONE OF THE ICONIXSPEED TIPS REMAINED IN THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 20078796 ↗MalfunctionMay 9, 2024Fracture; Fracture
IT WAS REPORTED THAT WHEN THE ICONIXSPEED WAS DRIVEN INTO THE ROTATOR CUFF, THE NEEDLE PORTION OF THE INSERTER BROKE OFF. THE BROKEN PART HAS NOT BEEN REMOVED. THE DOCTOR DECIDED TO REMAIN THE BROKEN PART IN THE PATIENT BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 19282208 ↗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 18784234 ↗InjuryFeb 22, 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 18760454 ↗MalfunctionJul 7, 2021Break
THE DEVICE WAS SENT IN WITH A BROKEN TIP AND IT WAS REPORTED THAT IT BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12132186 ↗MalfunctionMar 10, 2020Nonstandard Device; Expiration Date Error; Nonstandard Device
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9814197 ↗InjuryFeb 26, 2020Break; Break
IT WAS REPORTED THAT THE DISTAL TIP OF THE ANCHOR INSERTER BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9757223 ↗
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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