ULTRABUTTON 72205601Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556817216), received between May 3, 2023 and Apr 15, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ACL REPAIR, AN ULTRABUTTON DEVICE GOT JAMMED IN THE MESH AND WOULD NOT MOVE. THE FEMORAL TUNNEL ENDED UP BEING 40CM, WHICH WAS TOO LARGE, AND THERE WASN'T ENOUGH GRAFT LEFT FOR THE TIBIA. THE PROCEDURE WAS RESUMED, AFTER A 40-MINUTE DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886326 ↗
• MalfunctionNov 20, 2025Positioning Problem; Material Split, Cut or Torn; Positioning Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, ONE SUTURE SNAPPED OF THE ULTRABUTTON DURING TIBIAL REDUCTION, AND THE BUTTON FAILED TO LOCK EVENLY IN POSITION. THE SNAPPED SUTURE WAS RETHREADED, THIS WORKED TO AN EXTENT, BUT THE BUTTON CONTINUED TO ELONGATE AND NOT LOCK WHEN TENSIONED. THE MAKE THE BUTTON WORKED, THE SURGEON HAD TO ADD AN ADDITIONAL PROCEDURE TO TIE DOWN THE BUTTON TO THE TIBIA. THE PROCEDURE WAS RESUMED USING THE SAME FAULTY DEVICE, THERE WAS A SURGICAL DELAY; HOWEVER, THE DURATION WAS NOT REPORTED. NO FURTHER COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610907 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE ULTRABUTTON TENSION WAS INCORRECT, PROMPTING THE SPECIALIST TO USE A PLASTIC HAND BAR TO TENSION THE SUTURES AND REDUCE THE BUTTON. THE BUTTON BROKE CLEAN AWAY FROM THE SUTURES AND WAS REMOVED. IN CONSEQUENCE, THE GRAFT HAD TO BE REMOVED FROM THE KNEE, REQUIRING AN ADDITIONAL PROCEDURE TO DISSECT TO THE FEMORAL ULTRABUTTON AND CUT IT OFF. THE GRAFT WAS EXTRACTED BY PULLING FROM THE MEDIAL PORTAL, RE-STITCHED, AND A NEW FEMORAL ULTRABUTTON WAS PASSED SUCCESSFULLY. THERE WAS A SURGICAL DELAY; HOWEVER, THE DURATION WAS NOT REPORTED. NO FURTHER COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610883 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, IT WAS NOTICED THAT A ULTRABUTTON TIB MED ADJ FIXATION DEV SNAPPED AFTER BUTTON WAS REDUCED AND AS THE SURGEON WAS EXTENDING THE OPERATING LEG. NO FRAGMENTS WERE LEFT IN THE PATIENT, ALL COMPONENTS WERE EXTRA-ARTICULAR AND RETRIEVED SAFELY. THE GRAFT HAD TO BE REMOVED, AND BUTTONS REMOVED, THEN GRAFT WAS PREPARED WITH NEW BUTTONS. THE PROCEDURE WAS PERFORMED, AFTER A DELAY GREATER THAN 30 MIN, USING A COMPETITOR DEVICE AN ARTHREX TIGHTROPE ABS IMPLANT. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280274 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL FIXATION, UPON TENSIONING THE TIBIAL ULTRABUTTON FIXATION DEVICE, ALL THE SUTURES BROKE FROM THE BUTTON, CAUSING THE FIXATION TO FAIL. THE GRAFT WAS REMOVED, AND PREPARATION WAS UNDERTAKEN A SECOND TIME. THE SECOND ULTRABUTTON FIXATION DEVICE FAILED IN THE SAME WAY AS THE FIRST. THE GRAFT HAD TO BE REMOVED AGAIN, AND THE PREPARATION UNDERTAKEN FOR A THIRD TIME. ON THIS OCCASION, AN ALTERNATIVE LOT NUMBER WAS USED, AND THE IMPLANT WORKED AS EXPECTED. AN INTRA-OP DELAY OF 1 HOUR WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900996 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING A QUAD ACL RECONSTRUCTION PROCEDURE, THE GRAFT OF THE ULTRABUTTON PASSED INTO THE FEMUR AND THE SURGEON WAS ABOUT TO TENSION THE DEVICE IN EXTENSION, HERE THE BUTTON IS AT MAXIMUM TENSION AND THE SURGEON THEN PUT THE LEG IN 90 DEGREES OF FLEXION AND THE BUTTON ELONGATED AND LOOSED TENSION. THE LEG WAS PUT BACK IN EXTENSION TO RE-TENSION AND ONE OF THE REDUCTION SUTURE SNAPPED. THE TEAM MANAGED TO RETRIEVE THE SUTURE IN THE JOINT, AS IT WAS IN THE TIBIAL TUNNEL AND THREADED THE SUTURE BACK THROUGH THE BUTTON, HOWEVER, WHEN IT WAS HELD WITH A CLIP IN FLEXION, TRYING TO RE-TENSION THE SUTURES, THE BUTTON WOULD NOT REDUCE AS THE REDUCTION HAD SNAPPED. A LATERAL INCISION WAS MADE TO CUT THE GRAFT OUT AND THE FEMORAL BUTTON WAS CUT OFF TO RETRIEVE IT. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801161 ↗
• MalfunctionAug 13, 2025Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE CRADDLE OF THE ULTRABUTTON SNAPPED ON THE INSIDE OF THE JOINT, SO IT WAS NOT SITTING FLUSH AND WAS NOT TENSIONED. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794266 ↗
• MalfunctionJun 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING SURGERY, THE TENSIONING SUTURE OF AN ULTRABUTTON TIBIAL ADJUSTABLE ANCHOR TORN WHILE PROVIDING TENSION. THE ANCHOR AND SUTURE WERE SUCCESSFULLY REMOVED FROM THE PATIENT BY USING GRASPERS AND FORCEPS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199789 ↗
• MalfunctionMay 31, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE LOOP WAS TIGHTENED, THE SUTURES OF TWO (2) ULTRABUTTONS DID BREAK OFF, THE SUTURES OF THE ULTRABUTTONS DID SNAP OFF BY THE BUTTON. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120546 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PULLING SUTURE OF THE ULTRABUTTON BROKE WHILE PROVIDING TENSION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118015 ↗
• InjuryDec 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REVISION ACL SURGERY A PATIENT THAT HAD PREVIOUSLY HAD AN ACL SURGERY BY THE SAME SURGEON ON THE (B)(6) 2024 WHERE AN ULTRABUTTON TIB WAS USED FOR FIXATION. ON THE REVISION SURGERY IT WAS DISCOVERED THAT THE QUADS GRAFT HAD BECOME COMPLETELY SEPARATED FROM THE ULTRABUTTON TIB CONSTRUCT. THE PATIENT REPORTED INSTABILITY. THE DEVICE WAS EXPLANTED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE PATIENT SLIPPED AND FALL ON THE WET GROUND. THE POST OPERATIVE PLAN WAS PHYSICAL THERAPY. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Fall

  MAUDE report 20973171 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ULTRABUTTON SUTURE GOT BROKEN DURING PULLING OF THE SUTURE. THE BROKEN SUTURES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES, WITH THE SAME ULTRABUTTON DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783785 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, WHEN THE ULTRABUTTON WAS INSERTED INTO A BONE HOLE AND ADJUSTABLE SUTURE WAS APPLIED TENSION, THE ADJUSTABLE SUTURE AND LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 3 HOURS USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060772 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT DURING AN AUTOGRAFT QUAD ACL RECONSTRUCTION, AT THE END OF THE CASE, THE CRADLE OF THE TIBIAL ULTRABUTTON PULLED THROUGH THE GRAFT AND LOST FIXATION OF THE BUTTON AGAINST THE BONE. SINCE THE TIBIAL ULTRABUTTON RIPPED OUT, THE DR ONLY USED THE BUTTON FROM THE UB TIBIA DEVICE AND TIED THE SUTURES TO THE BUTTON., THEN BACKED UP THOSE SUTURES WITH A FOOTPRINT ANCHOR BELOW THE TUNNEL FOR THE GRAFT. DR DRILLED A NEW BONE HOLE FOR THE FOOTPRINT ANCHOR. THERE WAS A SURGICAL DELAY OF AROUND 15 MINUTES. DR IS SATISFIED WITH THE FIXATION. NO FURTHER COMPLICATION WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 16861967 ↗