OrthAlign PlusRecalls & reported problems across all models
Orthalign, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 13 models of OrthAlign Plus by Orthalign, Inc. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2016 and Jan 20, 2026 — classified as 12 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (38 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 OrthAlign Plus problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings38
- Incorrect Measurement11
- No Apparent Adverse Event7
- Adverse Event Without Identified Device or Use Problem5
- Material Separation4
- Insufficient Device Problem Information2
- Break1
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Known Impact Or Consequence To Patient10
- Joint Laxity6
- Foreign Body In Patient4
- Bone Fracture(s)2
- Insufficient Information2
- Hip Fracture1
- No Consequences Or Impact To Patient1
OrthAlign Plus models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OrthAlign Plus 403087-06Orthopedic Stereotaxic Instrument18 reports
- OrthAlign Plus 403001-05Orthopedic Stereotaxic Instrument15 reports
- OrthAlign Plus 403001-08Orthopedic Stereotaxic Instrument6 reports
- OrthAlign Plus 403001Orthopedic Stereotaxic Instrument6 reports
- OrthAlign Plus 403001-06Orthopedic Stereotaxic Instrument5 reports
- OrthAlign Plus 403001-08-USOrthopedic Stereotaxic Instrument4 reports
- OrthAlign Plus 403001-04Orthopedic Stereotaxic Instrument4 reports
- OrthAlign Plus 403185Orthopedic Stereotaxic Instrument4 reports
- OrthAlign Plus 403087Orthopedic Stereotaxic Instrument3 reports
- OrthAlign Plus 403349Orthopedic Stereotaxic Instrument1 report
- OrthAlign Plus 403305Orthopedic Stereotaxic Instrument1 report
- OrthAlign Plus 403341Orthopedic Stereotaxic Instrument1 report
- OrthAlign Plus 403028Orthopedic Stereotaxic Instrument1 report
Recent OrthAlign Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE SURGEON QUESTIONED THE ORIGINAL FLEXION NUMBER OF (10.5) AS HE THOUGHT IT SHOULD HAVE BEEN CLOSER TO 3 DEGREES. SURGEON ALSO QUESTIONED THE SLOPE AND VARUS/VALGUS ON THE TIBIA (SURGEON AIMS FOR 4/4.5 SLOPE AND 0/0.5 VARUS). THE PATIENT WAS A LARGER PATIENT WITH A BIGGER BONE STRUCTURE AND NO SEVERE DEFORMITIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24125527 ↗MalfunctionApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
DURING THE FEMORAL MANEUVER MULTIPLE ATTEMPTS WERE MADE TO ACHIEVE REGISTRATION. THE NUMBERS SEEMED OFF AND THE PADDLES DID NOT ALIGN WITH THE BONE. THE NAVIGATION UNIT WAS REPROVED AND RESET BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS COMPLETED WITH A SECOND NAVIGATION UNIT AND A SECOND REFERENCE SENSOR. NO INJURY, DEATH, OR INCREASED TOURNIQUET TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21930020 ↗MalfunctionFeb 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
DURING THE FEMORAL MANEUVER MULTIPLE ATTEMPTS WERE MADE TO ACHIEVE REGISTRATION. THE NUMBERS SEEMED OFF AND THE PADDLES DID NOT ALIGN WITH THE BONE. THE NAVIGATION UNIT WAS REPROVED AND RESET BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS COMPLETED WITH A SECOND NAVIGATION UNIT AND A SECOND REFERENCE SENSOR. NO INJURY, DEATH, OR INCREASED TOURNIQUET TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470550 ↗MalfunctionOct 28, 2024Incorrect Measurement; Incorrect Measurement
SURGEON REPORTED THAT THE MEASUREMENT FOR THE TIBIAL CUT WAS INCORRECT. THE PROCEDURE WAS COMPLETED WITH STANDARD INSTRUMETNATION AND NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20550147 ↗MalfunctionOct 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
VERSION NUMBERS KEPT DRIFTING TO ZERO THROUGHOUT THE CASE. NO IMPACT TO PATENT. CASE COMPLETED WITH CONVENTIONAL INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20505626 ↗MalfunctionApr 24, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT V3 RING MIXED 2 PACK BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.
Patient problems: Insufficient Information
MAUDE report 19172018 ↗MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ALIGNMENT READINGS ARE OFF. WHEN SETTING UP FOR THE CORRECT SIDED HIP THE NUMBERS ON THE NAV UNIT SHOW RETROVERTED. RELATED TO REPORTS 3007521480-2023-00017 AND 3007521480-2023-00018.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18016217 ↗MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ALIGNMENT READINGS ARE OFF. WHEN SETTING UP FOR THE CORRECT SIDED HIP THE NUMBERS ON THE NAV UNIT SHOW RETROVERTED. RELATED TO REPORTS 3007521480-2023-00017 AND 3007521480-2023-00019.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18015450 ↗MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ALIGNMENT READINGS ARE OFF. WHEN SETTING UP FOR THE CORRECT SIDED HIP THE NUMBERS ON THE NAV UNIT SHOW RETROVERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18012027 ↗MalfunctionOct 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IN THE PREVIOUS CASE THE REFERENCE SENSOR WAS LEFT ON DURING IMPACTION. AFTER THAT THE NUMBERS SEEMED "OFF". WHEN THE SURGEON TRIED TO USE THE REFERENCE SENSOR IN THE NEXT CASE IT WOULD NOT PAIR WITH THE NAVIGATION UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18011916 ↗InjuryOct 12, 2023Incorrect Measurement; Incorrect Measurement
EVERYTHING CALIBRATED FINE, BUT THE CUT ON THE FEMUR WAS SIGNIFICANTLY OFF. THE SURGERY WAS COMPLETED WITH STANDARD INSTRUMENTS.
Patient problems: Joint Laxity
MAUDE report 17920461 ↗MalfunctionJun 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
SENSOR UNIT WOULD NOT CALIBRATE WITH THE NAVIGATION UNIT. A NEW OA+ UNIT WAS OPENED AND THEN IT SUCCESSFULLY CALIBRATED WITH THE SENSOR UNIT. THE DISTAL FEMORAL CUT WAS OFF BY A SIGNIFICANT AMOUNT.
Patient problems: Insufficient Information
MAUDE report 17056149 ↗MalfunctionApr 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
POSSIBLE SYSTEM ACCURACY ISSUE: INCORRECT PROBE SCALE VALUE. IT WAS REPORTED BY A DISTRIBUTOR THAT DURING OPERATION OF THE DEVICE, THE PROBE SCALE VALUE SHOWED ONE WHILE AT ZERO POSITION. THE PHENOMENON OCCURRED WITH COMBINATION OF THE PROBE SCALE AND THE REFERENCE SENSOR. THIS WAS A NON-CLINICAL INCIDENT (PHENOMENON DID NOT OCCUR DURING A SURGICAL PROCEDURE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820859 ↗MalfunctionMar 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEEALIGN ON (B)(6), 2023. SURGEON FELT THAT THE OSTEOTOMY QUANTITY WAS NOT VISUALLYN PROPER. THEREFORE, HE SWITCHED TO CONVENTIONAL INSTRUMENTS TO COMPLETE THE PROCEDURE. THE NAVIGATION UNIT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16588441 ↗InjuryFeb 20, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022. SURGEON DID THE FEMUR REGISTRATION AND INSTALLED THE GUIDE (V/V WAS ADJUSTED TO ZERO DEGREES) IN ACCORDANCE WITH THE PROCEDURE. HOWEVER, AFTER CUTTING THE DISTAL FEMUR BONE, SHE FOUND THAT IT WAS OBVIOUSLY VALGUS. SUBSEQUENTLY, SHE ADDITIONALLY CUT THE BONE TO ADJUST THE ALIGNMENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.
Patient problems: Joint Laxity
MAUDE report 16401930 ↗
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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