KneeAlign 2 402068Recalls & reported problems
Orthalign, Inc. · Threaded Pin, Headed, 46mm · Class 2
All models of KneeAlign 2 (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858704006442), received between Mar 16, 2019 and May 24, 2024 — classified as 1 injury, 2 malfunctions.
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
- No Apparent Adverse Event1
- Separation Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2024Break; Break
WHEN REMOVING THE PIN FROM THE MICROBLOCK THE PIN HEAD FRACTURED AND IT JAMMED IN THE PIN DRIVER. THE SURGEON HAD A HARD TIME REMOVING THE PIN FORM THE PATIENT BODY, BUT THE PIN WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392650 ↗InjuryMar 14, 2022Separation Problem; Separation Problem
IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEEALIGN ON(B)(6) 2022. WHEN REMOVING A SHORT PIN ON FEMORAL SIDE, THE PIN BROKE. THE BROKEN PIN WAS REMOVED FROM THE PATIENT BODY. NO ADVERSE EVENT OCCURRED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13758057 ↗MalfunctionMar 16, 2019No Apparent Adverse Event; No Apparent Adverse Event
HEAD OF THE PIN BROKE OFF WHEN USING THE PIN DRIVER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8426670 ↗
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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.
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