EZout 7812058001KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327294415), received between Apr 18, 2019 and Dec 17, 2019 — classified as 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE LONG BLADE BROKE PROXIMALLY TO THE SAW DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9483230 ↗
• MalfunctionApr 18, 2019Break; Break

  IT WAS REPORTED THAT DURING A HIP REVISION PROCEDURE, THE LONG EZOUT BLADE BROKE IN HALF. THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION OR DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529501 ↗