EZout 7812046001KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327294569), received between Sep 24, 2018 and Jan 22, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTED FOUND TO HAVE A TEAR, RIP, OR HOLE IN THE DEVICE PACKAGING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556997 ↗
• MalfunctionAug 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A REMOVAL OF THE ACETABULAR CUP, THE EZOUT BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10407783 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES OR DELAY AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903140 ↗