Precision Falcon 6625127090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540684349), received between Sep 30, 2019 and Sep 30, 2019 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE, WHILE CUTTING THE FEMUR, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE SURGEON WAS BENDING AND FLEXING THE BLADE WHEN ENTERING THE CUTTING BLOCK, THERE WAS CONTACT WITH THE CUTTING GUIDE. IT WAS FURTHER REPORTED THAT THERE WAS A TEN MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136067 ↗