U2 Total Knee SystemRecalls & reported problems across all models

We found 26 models of U2 Total Knee System by United Orthopedic Corp. in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2024 and Jun 25, 2026 — classified as 1 injury, 59 malfunctions.

The most frequently reported specific device problem is “Break” (59 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

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

U2 Total Knee System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 20, 2026Open, Classified

   Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

   Z-2886-2026 · Root cause: Process design · names 6 of these models · Recall details · FDA record ↗

2. May 20, 2026Open, Classified

   Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

   Z-2885-2026 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

3. May 20, 2026Open, Classified

   Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

   Z-2883-2026 · Root cause: Process design · names 12 of these models · Recall details · FDA record ↗

4. Mar 19, 2026Open, Classified

   Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

   Z-2898-2026 · Root cause: Device Design · Recall details · FDA record ↗

5. Mar 19, 2026Open, Classified

   Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.

   Z-2897-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported U2 Total Knee System problems

U2 Total Knee System models

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

• U2 Total Knee System 9323-5516

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5335

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5336

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5337

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5338

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5339

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5340

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5511

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5512

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5513

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5514

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5515

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5521

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5522

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5523

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5524

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5525

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5526

  Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
  1 recall0 reports
• U2 Total Knee System 9323-5310

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5312

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5333

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9323-5334

  Orthopedic Manual Surgical Instrument
  1 recall0 reports
• U2 Total Knee System 9404-2902

  Orthopedic Manual Surgical Instrument
  48 reports
• U2 Total Knee System 9404-2903

  Orthopedic Manual Surgical Instrument
  7 reports
• U2 Total Knee System 9304-4103-RE

  Impactor
  4 reports
• U2 Total Knee System 2103-1640

  Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
  1 report

Recent U2 Total Knee System adverse event reports

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

• InjuryJun 25, 2026Insufficient Device Problem Information

  A COMPLAINT CASE REGARDING THE FEMORAL COMPONENT WAS RECEIVED BY THE U.S. SUBSIDIARY ON (B)(6) 2026. A 59-YEAR-OLD FEMALE PATIENT UNDERWENT TKA SURGERY USING THE U2 TOTAL KNEE SYSTEM ON (B)(6) 2025. THE PATIENT RETURNED WITH CONTINUED PAIN, WORSENED PAIN, AND STIFFNESS. THE X-RAY SHOWED SEVERAL SMALL RADIOPAQUE SPOTS ADJACENT TO THE BONE CUT SURFACE OF THE FEMORAL COMPONENT. THE PHYSICIAN INDICATES THAT FURTHER EVALUATION OF THE PATIENT'S CONDITION IS NEEDED TO DETERMINE WHETHER REVISION SURGERY IS REQUIRED.

  Patient problems: Limb Pain; Loss of Range of Motion

  MAUDE report 25631332 ↗
• 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

  AFTER PUNCHING THE KNEE, DR. (B)(6) REMOVED THE TIBIAL TOWER WITH A SLAP HAMMER. AFTER THE TOWER AND BASEPLATE WERE REMOVED ONE OF THE TOWER SPIKES BROKE OFF. THE CASE WAS COMPLETED SUCCESSFULLY; THERE WAS NO DELAY IN THE CASE. THE PATIENT WAS UNAFFECTED, AND STANDARD SURGICAL PROTOCOL WAS FOLLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197198 ↗
• 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 ↗
• MalfunctionMay 21, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED TIBIAL TOWER COMPONENT #3~#5 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 22067374 ↗
• MalfunctionMar 10, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, TWO SPIKES ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED AFTER PERFORMING KEEL PUNCH IMPACTION PROCEDURE. THE SURGEON IDENTIFIED THE TWO BROKEN SPIKES EMBEDDED IN THE BONE AND CAREFULLY EXTRACTED THE SPIKES FROM THE BONE AND CONTINUED WITH THE SURGERY, THERE WAS NO DELAY IN THE CASE. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS 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 21556768 ↗
• MalfunctionJan 17, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, ONE SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED AFTER PERFORMING KEEL PUNCH IMPACTION PROCEDURE. THE SURGEON IDENTIFIED THE ONE BROKEN SPIKE ON THE TIBIAL BASEPLATE AND CAREFULLY REMOVED THE SPIKE FROM THE TIBIAL BASEPLATE AND CONTINUED WITH THE SURGERY, THERE WAS NO DELAY IN THE CASE. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS 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 21176314 ↗
• 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 ↗
• MalfunctionJan 17, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED THE TIBIAL TOWER COMPONENT #3~#5 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 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 21176268 ↗
• MalfunctionDec 26, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED TIBIAL TOWER COMPONENTS # 3~# 5 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT TWO SPIKES WITHIN THE TIBIAL TOWER WAS BROKEN AND HAD BECOME EMBEDDED IN THE PATIENT'S BONE. THE SURGEON UTILIZED A SPECIALIZED TOOL CALLED A "RONGEUR" TO CAREFULLY REMOVE THE BROKEN SPIKES FROM THE PATIENT'S BONE. AFTER REMOVING THE BROKEN SPIKES, 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 21023805 ↗
• MalfunctionDec 26, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, ONE SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED AFTER PERFORMING KEEL PUNCH IMPACTION PROCEDURE. THE SURGEON IDENTIFIED THE ONE BROKEN SPIKE ON THE TIBIAL BASEPLATE AND CAREFULLY REMOVED THE SPIKE FROM THE TIBIAL BASEPLATE AND CONTINUED WITH THE SURGERY, THERE WAS NO DELAY IN THE CASE. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS 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 21023804 ↗
• MalfunctionOct 30, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, A SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED FROM THE PREPARED TIBIA. THE SURGEON IDENTIFIED THE BROKEN FRAGMENT EMBEDDED IN THE BONE AND USED RONGUER TO CAREFULLY EXTRACT IT, RESULTING IN A BRIEF 2-MINUTE DELAY. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS 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 20564460 ↗

Other United Orthopedic Corp. products

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• "UNITED" USTAR II Hip System9 models · 4 reports · 3 recalls
• USTAR II Knee System12 models · 0 reports · 1 recall