KneeAlign 2Recalls & reported problems across all models
Orthalign, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 8 models of KneeAlign 2 by Orthalign, Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2017 and Sep 23, 2026 — classified as 13 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19 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
Reports received per month, all models
Most reported KneeAlign 2 problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings19
- Adverse Event Without Identified Device or Use Problem9
- Insufficient Device Problem Information6
- Break5
- No Apparent Adverse Event5
- Non Reproducible Results3
- Contamination /Decontamination Problem1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Joint Laxity10
- No Known Impact Or Consequence To Patient5
- Not Applicable2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Intraoperative Cardiac Valve Injury1
- Joint Disorder1
- Metal Related Pathology1
KneeAlign 2 models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- KneeAlign 2 133632Orthopedic Stereotaxic Instrument30 reports
- KneeAlign 2 402042Orthopedic Stereotaxic Instrument6 reports
- KneeAlign 2 403189Orthopedic Stereotaxic Instrument4 reports
- KneeAlign 2 133631Orthopedic Stereotaxic Instrument3 reports
- KneeAlign 2 402068Orthopedic Stereotaxic Instrument3 reports
- KneeAlign 2 401612Orthopedic Stereotaxic Instrument2 reports
- KneeAlign 2 401587Orthopedic Stereotaxic Instrument1 report
- KneeAlign 2 402043Orthopedic Stereotaxic Instrument1 report
Recent KneeAlign 2 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873810 ↗MalfunctionFeb 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED, THE SURGEON QUESTIONED VARUS/VALGUS ACCURACY OF FEMORAL CUT. REPORTER WAS IN THE CASE AND EVERYTHING WENT AS IT SHOULD. THE SURGEON REDID THE MOVE THREE TIMES AND KEPT GETTING THE SAME RESULT AND HE FELT THE 0.0 WAS CUTTING VALGUS INTO THE CUT. HE THEN WENT TO 1.0 VARUS TO PLAY ON THE SAFE SIDE AND PROCEEDED TO CUT THE FEMUR AND STILL FELT IT WAS CUTTING VALGUS INTO THE FEMUR. THE CASE ENDED UP GOOD HOWEVER HE DIDN'T LIKE THE FEMORAL CUT AND WAS QUESTIONING THE ACCURACY. SURGEON'S OTHER TWO CASES TODAY HAD NO ISSUES. [THE SURGEON] DID NOT GO AND MAKE A REVISION CUT HE CONTINUED WITH THE PROCEDURE AND MADE UP FOR THE VALGUS IN OTHER AREAS.
Patient problems: Joint Laxity
MAUDE report 24241763 ↗MalfunctionDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE SENSOR FAILED AND THE DOCTOR STATED THE SENSOR HE WAS USING WAS INACCURATE BY A FEW DEGREES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839168 ↗MalfunctionJun 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE SURGEON WAS ABLE TO REGISTER THE CENTER OF THE FEMORAL HEAD, BUT WHEN HE POSITIONED THE DEEP FLEXION AND LIFTED THE AFFECTED SIDE TO FIT THE BLACK BALL IN THE BOX AGAIN, IT WAS MARKED 20° OF FLEXION, AND HE HAD TO MAKE MAXIMUM ADJUSTMENTS WITH A SCREWDRIVER TO TRY TO MATCH 3° OF FLEXION. AS A RESULT, THE PADDLE COULD NOT BE ATTACHED TO THE GUIDE ROD, AND ACCURATE DISTAL FEMORAL OSTEOTOMY WAS NOT POSSIBLE. HE TRIED THE TIBIA AS IT WAS, AND THE TIBIA COULD BE OSTEOTOMIZED WITHOUT ANY PROBLEMS. THE SURGEON WAS UNABLE TO SET THE DISTAL FEMORAL OSTEOTOMY VOLUME SO THE CUT BLOCK WAS MOVED AND RE-PINNED MULTIPLE TIMES. THIS MAY HAVE AFFECTED THE FLEXION-EXTENSION AND INTERNAL/EXTERNAL ROTATION OF THE CUT BLOCK. THE SURGEON COMPLETED THE SURGERY WITH CONVENTIONAL INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133931 ↗InjuryApr 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PATIENT SUFFERED A POPLITEAL ARTERY INJURY DURING THE OPERATION. HE WAS TRANSFERRED TO (B)(6) HOSPITAL AND CONFIRMED THE CAUSE WITH HIS THEN PRIMARY SURGEON. THE SURGEON PREDICTED THAT THE PERSONA PIN MIGHT HAVE PENETRATED THE TIBIA.
Patient problems: Unspecified Vascular Problem
MAUDE report 21894795 ↗MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
SURGEON BELIEVES CALIBRATION WAS INACCURATE. BLAMING AGE OF THE REFERENCE SENSOR. CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROEDURE AND MAKE THE DISTAL FEMUR AND TIBIA CUTS. THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573573 ↗MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
SURGEON BELIEVES CALIBRATION WAS INACCURATE. BLAMING AGE OF THE REFERENCE SENSOR. CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE AND MAKE THE DISTAL FEMUR AND TIBIA CUTS. THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573547 ↗MalfunctionJan 8, 2025Product Quality Problem; Product Quality Problem
A SMALL BURR WAS FOUND ON THE SHAFT OF A NEW MICROBLOCK. ANOTHER MICROBLOCK OF THE SAME LOT WAS CHECKED AND IT ALSO HAD A BURR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103132 ↗MalfunctionDec 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
DURING PROCEDURE NAVIGATION UNIT MADE A LONG BEEPING SOUND AND SIGNALED TO CHANGE BATTERY IN THE REFERENCE SENSOR. AFTER THAT THE CUTS MAY HAVE BEEN OFF. PROCEDURE COMPLETED WITH TRADITIONAL INSTRUMENTATION.
Patient problems: Intraoperative Cardiac Valve Injury
MAUDE report 20832908 ↗MalfunctionNov 13, 2024Break; Break
THE PIN DRIVER BROKE DURING SURGERY WHEN TRYING TO REMOVE ONE OF THE TIBILA RESECTOR PINS. THE PIN WAS ABLE TO BE REMOVED WITH A PAIR OF PLIERS. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677423 ↗MalfunctionOct 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
DEVICE WAS SHOWING AN OSTEOTOMY OF ABOUT 14MM, BUT WHEN THE SURGEON CONFIMED WITH MANULA INSTRUMENTS HE FOUND THE OSTOTOMY TO BE 9MM. THE SURGEON CHANGED THE PINNING POSITION AND COMPLETED THE PROCEDURE. NO ADVERSE EVENT OR PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397225 ↗MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
MICROBLOCK IS LOOSE AND DROPS DOWN DURING USE. THE SURGEON IS UNCERTAIN WHERE TO MEASURE. THERE WAS NO IMPACT TO PATIENT AND THE CASE WAS COMPLETED WITH THE MICROBLOCK AND THE REST OF THE ORTHALIGN NAVIGATION SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20279618 ↗MalfunctionJul 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
SURGEON BELIEVES CALIBRATION WAS INACCURATE. CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROEDURE AND MAKE THE DISTAL FEMUR AND TIBIA CUTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19772938 ↗InjuryJul 9, 2024Mechanical Problem; Mechanical Problem
THE SURGEON REPORTED THAT THE TREADED PIN INTERFERED WITH THE PIN HOLE OF THE MICRBLOCK AND JAMMED IN THE PIN HOLE DUE TO PIN ECCENTRICITY DURING DRILLING.
Patient problems: Metal Related Pathology; No Clinical Signs, Symptoms or Conditions
MAUDE report 19702151 ↗MalfunctionJun 19, 2024Break; Break
TIBIAL CUTTING BLOCK HAS A PIECE OF DAMAGED METAL STICKING OFF OF IT THAT IS SHARP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566956 ↗
Other Orthalign, Inc. products
All Orthalign, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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