ATTUNE 2999-65-994Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295453277), received between Aug 22, 2023 and May 1, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATED THE STYLUS WAS NOT CALIBRATED AND THAT THE BALANCER WAS STICKING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059792 ↗
• MalfunctionJan 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BALANCE SIZER CAME APART IN PRE CASE SET UP, ALL COMPONENTS WERE TAKEN OUT OF CASE AND A NEW BALANCE SIZER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192745 ↗
• MalfunctionDec 30, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE MTO BALANCED SIZER NO LONGER FUNCTIONS PROPERLY. THIS WAS DISCOVERED DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE. THE SURGEON STILL MANAGED TO USE THE INSTRUMENT SO THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926144 ↗
• MalfunctionJul 24, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE BALANCE SIZER WOULD NOT LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591212 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED THAT THE MTO BALANCER WELD BROKE AND INSTRUMENT COMPLETELY FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282249 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT THE MTO BALANCER WELD BROKE AND INSTRUMENT COMPLETELY FELL APART. THERE WAS UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235307 ↗
• MalfunctionJun 10, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE FIRST ATTUNE BALANCER LOCKING LEVER IS LOOSE AND DOES NOT LOCK TIGHT ENOUGH. THE 2ND ATTUNE BALANCER BINDS UP UNDER TENSION PER THE SURGEONS ADVISORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176540 ↗
• MalfunctionJun 10, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement

  IT WAS REPORTED THAT THE FIRST ATTUNE BALANCER LOCKING LEVER IS LOOSE AND DOES NOT LOCK TIGHT ENOUGH. THE 2ND ATTUNE BALANCER BINDS UP UNDER TENSION PER THE SURGEONS ADVISORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176456 ↗
• MalfunctionFeb 29, 2024Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT SURGEON WAS TENSIONING BAL SIZER WITH LAMINA SPREADER. UPON FURTHER INSPECTION AFTER THE CASE, SALES REP NOTICED SMALL CRACKS ON BOTH SIDES OF THE PADDLES CAUSING THE SIZER TO BE FLEXED AND NEEDS REPLACED. THERE WAS NO DELAY IN THE SURGERY AND NO PIECES BROKE OFF WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809134 ↗
• MalfunctionSep 29, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE MTO BALANCER IS CEASING UP A BIT WHEN UNDER TENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842545 ↗
• MalfunctionSep 26, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ATTUNE MTO BALANCER WAS CEASING UP UNDER TENSION DUE TO AN INTERNAL BINDING THAT COULD BE IDENTIFIED.

  Patient problems: Insufficient Information

  MAUDE report 17816373 ↗
• MalfunctionAug 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PS FOOT OF THE INSTRUMENT WOULD NO FULLY ENGAGE AND BECAME STUCK UPON TRYING TO REMOVE FROM THE INSTRUMENT BODY. PRODUCT WAS MARKED "NFCU" AS IT WAS INTENDED FOR TRAINING PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595945 ↗