KneeAlign 2 401612Recalls & reported problems
Orthalign, Inc. · Universal Tibial Cutting Block · Class 2
All models of KneeAlign 2 (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858704006329), received between Jun 19, 2024 and Apr 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Vascular Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 Orthopedic Stereotaxic Instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page