ULTRABUTTON 72205602Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556817223), received between Dec 2, 2024 and Feb 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE LOOP OF ONE (1) ULTRABUTTON TIB GOT ENLARGED WHILE CYCLING AFTER THE DEPLOYMENT. THE DOCTOR REMOVED THE BUTTON BY CUTTING THE LOOP AND PUT A NEW BUTTON WITH A SCREW. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24286000 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE BROKE WHILE TENSIONING AFTER FIXING IT ON THE TIBIAL SIDE. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE AND USING AN ULTRATAPE, THERE WAS DELAY GREATER THAT 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110387 ↗
• MalfunctionDec 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A QUAD ST ACL RECONSTRUCTION SURGERY, THE LOOP OF THE ULTRABUTTON TIB MEDIUM ADJUSTABLE FIXATION DID NOT REDUCE ON THE FIRST ATTEMPT WITH THE DEVICE, THE SURGEON EXPERIENCED EXTREME STIFFNESS, MAKING IT DIFFICULT TO MOVE, RESULTING IN THE BUTTON TEARING OFF THE GRAFT, WHICH COMPROMISED THE ULTRABUTTON QUAD ADJUSTABLE FIXATION FEMORAL ATTACHMENT, IT WAS UNABLE TO BE USED ON THE REMAINING GRAFT. ON THE SECOND ATTEMPT, WITH THE SECOND ULTRABUTTON TIB MEDIUM ADJUSTABLE FIXATION, THE TIBIAL BUTTON WAS TESTED OUTSIDE THE KNEE JOINT, BUT IT WOULD NOT REDUCE DESPITE FULL-FORCE PULLING, DIFFERENT ANGLES, AND MULTIPLE REDUCTION ATTEMPTS. WHEN A THIRD DEVICE WAS OPENED, A LARGE ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE, IT WAS FOUND THAT THE BLUE SUTURE WENT THROUGH THE REDUCING SUTURES, THEREFORE, THE SURGEON REMOVED AND ADDED THEIR OWN SUTURE TO BE ABLE TO REDUCE THAT ONE. THE PROCEDURE WAS COMPLETED USING A QUAD BUTTON AND TIB BUTTON LARGE BACKUP DEVICES. THE SURGERY TOOK 6 AND A HALF HOURS, THEREFORE, THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s); Perforation

  MAUDE report 20824722 ↗