U2 Total Knee System 9304-4103-RERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04719886890457), received between May 8, 2024 and Jun 26, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event; Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event

  THE SURGEON HAD PREPARED THE FEMORAL POSTERIOR STABILIZED (PS) NOTCH, WHICH IS A SPECIFIC AREA ON THE FEMUR BONE WHERE THE PS COMPONENT OF A TOTAL KNEE REPLACEMENT IS POSITIONED. DURING THE PROCEDURE, THE SURGEON REMOVED THE PS IMPACTOR, AND IT WAS NOTED THAT THE INSTRUMENT ASSEMBLY HAD BECOME DAMAGED. THIS TYPE OF DAMAGE TO A SURGICAL INSTRUMENT IS NOT UNCOMMON AND CAN OCCUR DUE TO THE FORCES AND STRESSES INVOLVED IN THE BONE PREPARATION PROCESS. DESPITE THE DAMAGE TO THE INSTRUMENT, THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ANY DELAYS OR COMPLICATIONS. THIS WAS POSSIBLE BECAUSE THE PS NOTCH HAD ALREADY BEEN SUCCESSFULLY PREPARED PRIOR TO THE INSTRUMENT DAMAGE. THE DAMAGED INSTRUMENT HAD ALREADY SERVED ITS PURPOSE, AND THE SURGEON WAS ABLE TO PROCEED WITH THE REMAINDER OF THE SURGICAL STEPS. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES OR DELAYS, AS THE INSTRUMENT HAD ALREADY PERFORMED ITS INTENDED FUNCTION OF PREPARING THE PS NOTCH PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612013 ↗
• MalfunctionJun 26, 2024Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event; Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event

  DURING THE PREPARATION FOR THE POSTERIOR STABILIZATION (PS) NOTCH PROCEDURE, THE SURGEON INADVERTENTLY MISALIGNED THE HOUSING IMPACTOR COMPONENT OF THE SURGICAL INSTRUMENT PRIOR TO STRIKING IT WITH A MALLET. THE GUIDE ARMS OF THE SURGICAL INSTRUMENT WERE DAMAGED DURING THE IMPACTION PROCESS, LIKELY DUE TO THE MISALIGNMENT. A REPLACEMENT GUIDE ARM COMPONENT WAS OBTAINED FROM ANOTHER SET OF THE SAME SURGICAL INSTRUMENT AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS UNAFFECTED BY THE INSTRUMENT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612012 ↗
• MalfunctionMay 8, 2024Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event; Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event

  THE SURGEON HAD PREPARED THE FEMORAL POSTERIOR STABILIZED (PS) NOTCH, WHICH IS A SPECIFIC AREA ON THE FEMUR BONE WHERE THE PS COMPONENT OF A TOTAL KNEE REPLACEMENT IS POSITIONED. DURING THE PROCEDURE, THE SURGEON REMOVED THE PS IMPACTOR, AND IT WAS NOTED THAT THE INSTRUMENT ASSEMBLY HAD BECOME DAMAGED. THIS TYPE OF DAMAGE TO A SURGICAL INSTRUMENT IS NOT UNCOMMON AND CAN OCCUR DUE TO THE FORCES AND STRESSES INVOLVED IN THE BONE PREPARATION PROCESS. DESPITE THE DAMAGE TO THE INSTRUMENT, THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ANY DELAYS OR COMPLICATIONS. THIS WAS POSSIBLE BECAUSE THE PS NOTCH HAD ALREADY BEEN SUCCESSFULLY PREPARED PRIOR TO THE INSTRUMENT DAMAGE. THE DAMAGED INSTRUMENT HAD ALREADY SERVED ITS PURPOSE, AND THE SURGEON WAS ABLE TO PROCEED WITH THE REMAINDER OF THE SURGICAL STEPS. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUES OR DELAYS, AS THE INSTRUMENT HAD ALREADY PERFORMED ITS INTENDED FUNCTION OF PREPARING THE PS NOTCH PRIOR TO THE DAMAGE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271561 ↗
• MalfunctionMay 8, 2024Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event; Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event

  DURING THE PREPARATION FOR THE POSTERIOR STABILIZATION (PS) NOTCH PROCEDURE, THE SURGEON INADVERTENTLY MISALIGNED THE HOUSING IMPACTOR COMPONENT OF THE SURGICAL INSTRUMENT PRIOR TO STRIKING IT WITH A MALLET. THE GUIDE ARMS OF THE SURGICAL INSTRUMENT WERE DAMAGED DURING THE IMPACTION PROCESS, LIKELY DUE TO THE MISALIGNMENT. A REPLACEMENT GUIDE ARM COMPONENT WAS OBTAINED FROM ANOTHER SET OF THE SAME SURGICAL INSTRUMENT AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT WAS UNAFFECTED BY THE INSTRUMENT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271555 ↗