OrthAlign Plus 403001-08-USRecalls & reported problems
Orthalign, Inc. · OrthAlign Plus Unit - Gap Balancing (US) · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810832031987), received between Oct 28, 2024 and Jan 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings3
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, 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 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.