U2 Total Knee System 9404-2903Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04719886892130), received between Jul 18, 2024 and Jan 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED THE TIBIAL TOWER COMPONENT #6~#7 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT ONE OF THE SPIKES WITHIN THE TIBIAL TOWER WAS BROKEN AND HAD BECOME EMBEDDED IN PATIENT'S BONE. THE SURGEON UTILIZED A RONGEUR TOOL TO CAREFULLY REMOVE THE BROKEN SPIKE FRAGMENTS FROM PATIENT'S BONE. AFTER REMOVING THE BROKEN SPIKE, THE SURGEON PROCEEDED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENTS. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THERE WAS A BRIEF DELAY OF 30 SECONDS WHICH DID NOT CONTRIBUTE TO ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197199 ↗
• MalfunctionJan 28, 2026Break; Material Separation; No Apparent Adverse Event

  DR. (B)(6) HAD COMPLETED HIS TIBIAL PUNCHING, AND WHILE REMOVING THE SIZE 6-7 TIBIAL TOWER, HE NOTICED ONE OF THE TOWER SPIKES HAD BROKEN OFF. THE SPIKE WAS LOCATED ON THE TIBIAL PLATEAU AND REMOVED. THE CASE WAS COMPLETED SUCCESSFULLY, THERE WAS NO DELAY IN THE CASE, AND THE PATIENT WAS UNAFFECTED. PATIENT BONE WAS SLIGHTLY HARDER THAN AVERAGE, PER (B)(6) (AGENT PRESENT WHEN SURGERY WAS PERFORMED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197197 ↗
• MalfunctionNov 6, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED THE TIBIAL TOWER COMPONENT #6~#7 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT ONE OF THE SPIKES WITHIN THE TIBIAL TOWER WAS BROKEN AND HAD BECOME EMBEDDED IN PATIENT'S BONE. THE SURGEON UTILIZED A ROGENUR TOOL TO CAREFULLY REMOVE THE BROKEN SPIKE FRAGMENTS FROM PATIENT'S BONE. AFTER REMOVING THE BROKEN SPIKE, THE SURGEON PROCEEDED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENTS. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THIS BRIEF DELAY DID NOT HAVE ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY. A REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493745 ↗
• MalfunctionMay 21, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED TIBIAL TOWER COMPONENT #6~#7 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT SPIKE WITHIN THE TIBIAL TOWER WAS BROKEN. THE BROKEN PIECE WAS FOUND IN THE BONE AND SAFELY EXTRACTED USING A RONGEUR TOOL. AFTER REMOVING THE BROKEN SPIKE, THE SURGEON PROCEEDED WITH THE REST OF THE PLANNED SURGICAL PROCEDURE. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THERE WAS A 5-MINUTE DELAY IN THE SURGERY TO REMOVE THE BROKEN SPIKE, AGENT PROVIDED FEEDBACK THAT THIS DELAY DID NOT HAVE ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067375 ↗
• MalfunctionJan 17, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED TIBIAL TOWER COMPONENT #6~#7 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT SPIKE WITHIN THE TIBIAL TOWER WAS BROKEN AND FELL ON THE BASEPLATE. AFTER REMOVING THE BROKEN SPIKE, THE SURGEON PROCEEDED WITH THE REST OF THE PLANNED SURGICAL PROCEDURE. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THIS BRIEF DELAY DID NOT HAVE ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176281 ↗
• MalfunctionJan 17, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED TIBIAL TOWER COMPONENT #6~#7 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT SPIKE WITHIN THE TIBIAL TOWER WAS BROKEN AND FELL ON THE BASEPLATE. AFTER REMOVING THE BROKEN SPIKE, THE SURGEON PROCEEDED WITH THE REST OF THE PLANNED SURGICAL PROCEDURE. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THIS BRIEF DELAY DID NOT HAVE ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176280 ↗
• MalfunctionJul 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING THE SURGERY SURGEON WAS PERFORMING AN ACTIVITY THAT REQUIRED IMPACTING A TIBIAL TOWER # 6~# 7 (PN:9404-2903) ONTO THE PATIENT'S TIBIA WITH A MALLET. THREE PINS ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING IMPACTED. THE BROKEN PINS WERE RETRIEVED AFTER REMOVING THE TRIAL TRAY, USING A TONSIL FORCEPS. THE SURGEON ENSURED NO PIECES WERE LEFT IN THE PATIENT'S BODY BY EXAMINING AND COMPARING THE RETRIEVED PINS TO THE INSTRUMENT. THERE WAS NO IMPACT ON THE PATIENT OR PROCEDURE AS THE TIBIAL TOWER HAD ALREADY COMPLETED ITS FUNCTION AND BROKEN PINS WERE RETRIEVED WHILE REMOVING THE TIBIAL TOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768588 ↗