ULTRABUTTONRecalls & reported problems across all models

We found 5 models of ULTRABUTTON by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 125 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2017 and Jun 29, 2026 — classified as 49 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Break” (54 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. 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

Most reported ULTRABUTTON problems

ULTRABUTTON models

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

• ULTRABUTTON 72290003

  Fastener, fixation, nondegradable, soft tissue
  103 reports
• ULTRABUTTON 72205601

  Fastener, fixation, nondegradable, soft tissue
  14 reports
• ULTRABUTTON 72205443

  Fastener, fixation, nondegradable, soft tissue
  4 reports
• ULTRABUTTON 72205602

  Fastener, fixation, nondegradable, soft tissue
  3 reports
• ULTRABUTTON 72205600

  Fastener, fixation, nondegradable, soft tissue
  1 report

Recent ULTRABUTTON adverse event reports

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

• MalfunctionJun 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A SURGERY, THE ULTRABUTTON FAILED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK UP DEVICE (INTERFERENCE SCREW). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661978 ↗
• MalfunctionJun 13, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, ONE (1) ULTRABUTTON ADJUSTABLE FIXATION DEVICE ADJUSTED THE POSITION THAT MADE IT POSSIBLE TO RAISE OR ENGAGE THE FEMUR, THE PLATE WAS REMOVED WHEN IT WAS TIME TO ADJUST THE POSITION AND IT WAS SMASHED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25495830 ↗
• MalfunctionJun 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, THE ULTRABUTTON ANCHOR WAS FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355688 ↗
• 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 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE SHORTENING SUTURES OF THE ULTRABUTTON SNAPPED BELOW THE BUTTON. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852107 ↗
• MalfunctionApr 1, 2026Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, THE ULTRABUTTON ADJUSTABLE LOOP SUTURE FRACTURE AND COULD NOT BE USED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT¿S CONDITION IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753377 ↗
• MalfunctionMar 30, 2026Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE FIRST AND SECOND SHORTENING LOOPS OF AN ULTRABUTTON DEVICE TORE. NO SHARP-EDGED INSTRUMENTS WERE USED DURING SHORTENING. THE TORN ULTRABUTTON COULD BE PULLED OUT OF THE THIGH MUSCLE BY THE TRACTION SUTURE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724190 ↗
• InjuryMar 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT ACL PROCEDURE, IT WAS NOTICED THAT ON THE DAY AFTER SURGERY, A FOLLOW-UP KNEE JOINT DR REVEALED THAT (1) ULTRABUTTON FIXATION DEVICE WAS LOOSE AND NOT TIGHTLY ATTACHED TO THE FEMORAL CORTEX. A SECOND SURGERY WAS PERFORMED ON FEBRUARY 6TH FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520196 ↗
• 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 ↗
• MalfunctionFeb 4, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE LOOP OF ONE (1) ULTRABUTTON GOT DAMAGED WHILE PULLING THE BUTTON IN THE FEMORAL TUNNEL. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL 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 24259610 ↗
• 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 29, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, DURING A POSTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, DURING THE PROCESS OF STRETCHING THE TENDON, THE COIL OF TWO (2) ULTRABUTTON TIGHTENED AND PREVENTED THE COMPLETION OF THE SUBSEQUENT OPERATION. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414211 ↗
• 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 ↗
• MalfunctionOct 8, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING THE TRUNAV TECHNIQUE, WHEN OPENING ONE (1) ULTRABUTTON IT WAS NOTICED THAT THE POUCH WAS TORN, AND THE DOUBLE PACKAGING WAS MISSING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23245813 ↗

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