IconixRecalls & reported problems across all models

We found 7 models of Iconix by Riverpoint Medical, LLC in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2023 and May 28, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (11 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Iconix recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 25, 2023Open, Classified

   Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.

   Z-0518-2024 · Root cause: Component design/selection · names 2 of these models · Recall details · FDA record ↗

Most reported Iconix problems

Iconix models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Iconix 3911-714-520

  Fastener, Fixation, Nondegradable, Soft Tissue
  1 recall11 reports
• Iconix 3911-714-521

  Fastener, Fixation, Nondegradable, Soft Tissue
  1 recall2 reports
• Iconix 3911-714-522

  Fastener, Fixation, Nondegradable, Soft Tissue
  12 reports
• Iconix 3911-523-731

  Fastener, Fixation, Nondegradable, Soft Tissue
  3 reports
• Iconix 3911-714-571

  Bit, Drill
  3 reports
• Iconix 3911-723-520

  Fastener, Fixation, Nondegradable, Soft Tissue
  1 report
• Iconix 3911-714-524

  Fastener, Fixation, Nondegradable, Soft Tissue
  1 report

Recent Iconix adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER, "SURGEON WAS ABOUT TO PUT THE FIRST ANCHOR IN THE PATIENT AND THE PA DID THE DRILLING, BIG PART OF THE TIP OF THE DRILL BROKE INSIDE THE PATIENT AND COULDN'T TAKE IT OUT. AFTER THE FIRST ANCHOR COMPLETELY PULLED OUT AFTER INSERTING IT, WE TRIED DRILLING IN ANOTHER SPOT THAT HAD BETTER BONE. I NOTICED THAT THE DRILL WENT STRAIGHT IN AND OUT WITHOUT ANY RESISTANCE SO THE TECH TOOK OUT THE DRILL AND NOTICED THE TIP WAS CLEARLY SNAPPED OFF. WE TOOK AN XRAY AFTER TO SEE IF IT WAS INSIDE THE PATIENT AND IT WAS. WE TRIED SEEING IF WE COULD FIND A TIP TO MAYBE REMOVE IT BUT IT ENDED UP BEING BURIED IN BONE SO STAYED THERE. SURGEON WAS VERY UPSET AND JUST ENDED UP PUTTING IN ANOTHER ANCHOR INSTEAD OF 2 MORE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325582 ↗
• MalfunctionMar 18, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER, "SURGEON WAS USING MALLET TO INSERT ICONIX KNOTLESS 1.4MM INTO THE ACETABULUM, ON INSERTION OF THE ANCHOR THE TIP OF THE INSERTED SHEATH SNAPPED OFF AND STAYED IN THE ACETABULUM, DUE TO THE NATURE OF WHERE IT WAS THE SURGEON DECIDED AGAINST REMOVING IT, ANOTHER ANCHOR WAS USED IN A DIFFERENT LOCATION WITH NIL ISSUES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630015 ↗
• MalfunctionMar 16, 2026Material Integrity Problem

  ACCORDING TO THE REPORTER: " 1.4MM HARD BONE DRILL BIT, BROKE OFF INSIDE THE ACETABULAR RIM DURING A HIP ARTHROSCOPY SURGERY, SURGEON MADE THE DECISION TO LEAVE A BIT OF THE DRILL IN THE BONE TO NOT CAUSE MORE DAMAGE TO THE BONE. THE SURGEON STATED THE BONE WAS VERY HARD AND THAT IS WHY IT MOST LIKELY HAPPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611799 ↗
• MalfunctionJan 29, 2026Patient Device Interaction Problem

  ACCORDING TO THE REPORTER:"DR. (B)(6) HAD EXPERIENCED SOFT BONE SETTINGS WHERE IMPLANTS DID NOT SET. SALESFORCE CASE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215449 ↗
• MalfunctionJan 29, 2026Patient Device Interaction Problem

  ACCORDING TO THE REPORTER:"DR. (B)(6) HAD EXPERIENCED SOFT BONE SETTINGS WHERE IMPLANTS DID NOT SET. SALESFORCE CASE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215447 ↗
• MalfunctionJan 6, 2026Patient Device Interaction Problem

  ACCORDING TO THE REPORTER:"THE ITEMS WERE WASTED BECAUSE THE IMPLANTS PULLED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981830 ↗
• MalfunctionJan 5, 2026Material Twisted/Bent

  ACCORDING TO THE REPORTER: "THE ANCHOR BENT ON INSERTION & PULLED OUT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958784 ↗
• MalfunctionDec 30, 2025Fracture; Fracture

  ACCORDING TO THE REPORTER: "THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS PATIENT CAME BACK IN FOR POST-OP X-RAYS AND THERE WAS A SMALL PIECE OF METAL THAT WAS DISCOVERED IN THEIR SHOULDER. THE PATIENT AND DR. HATZIDAKIS DECIDED TO SCHEDULE THE PATIENT FOR A SURGERY ON (B)(6) 2025. DURING THAT SURGERY ON (B)(6) 2025 IT WAS DISCOVERED THAT THIS PIECE OF METAL WAS A PART OF THE 1.4MM ICONIX KNOTLESS INSERTER. DR. HATZIDAKIS WAS ABLE TO SUCCESSFULLY REMOVE THIS PIECE OF THE 1.4MM ICONIX KNOTLESS INSERTER FROM THE PATIENTS SHOULDER DURING THAT SURGERY.."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924111 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  ACCORDING TO THE REPORTER: "WE WERE INFORMED BY A SURGEON TODAY THAT UPON DOING POST-OP X-RAYS IN HIS OFFICE, HE DISCOVERED A SMALL PIECE OF WHAT HE BELIEVED TO BE OF A STRYKER KNOTLESS ANCHOR THAT WAS IN THE SHOULDER. HE STATED THIS WAS HIS FIRST TIME USING THE STRYKER KNOTLESS. WE HAVE ALREADY CONTACTED OUR LOCAL STRYKER SALE REP AND LET THEM KNOW OF THE ISSUE. HE DID NOT REPORT KNOWING OF ANY OTHER ISSUES WITH THIS ANCHOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866171 ↗
• MalfunctionDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER: "ICONIX KNOTLESS ANCHOR IMPLANTED. SLIDING MECHANISM OF THE ANCHOR FAILED AND WAS STUCK. HAD TO TIE DOWN KNOTS LIKE A KNOTTED ANCHOR INSTEAD OF SLIDING INTO A KNOTLESS ANCHOR. NOTICED AFTER IMPLANTATION, WHEN TRYING TO PASS REPAIR STRAND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823791 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "ANCHOR PULLED OUT, SOFT BONE, TOUGH ANGLE. ITEM WASTED ON BILL ONLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360982 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "THIS CASE WITH DR.(B)(6). HE ATTEMPTED TO USE AN ICONIX KNOTLESS ANCHOR WITH THE HARD BONE DRILL BIT AND IT WAS UNSUCCESSFUL AND ABORTED THE ANCHOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360596 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "THIS CASE WITH DR.(B)(6). HE ATTEMPTED TO USE AN ICONIX KNOTLESS ANCHOR WITH THE HARD BONE DRILL BIT AND IT WAS UNSUCCESSFUL AND ABORTED THE ANCHOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360254 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "YES, THIS ANCHOR DID NOT PERFORM AS INTENDED. IT PULLED OUT OF THE BONE WITHOUT DEPLOYING. SO, IT DID NOT GET IMPLANTED INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359265 ↗
• MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, "WHILE USING THE ICONIX 2TT SWAGED WITH THE BLACK AND WHITE SUTURE, THE SUTURE GOT SUPER FRAYED AND THE SWAGED ASPECT OF THE ANCHOR SEPARATED. THIS IS THE THIRD TIME I'VE BEEN IN A CASE WITH THIS ISSUE. WE SWITCHED TO THE BLUE ANCHOR AND IT WORKED FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358879 ↗

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