EZout 7812060001KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327294408), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Vibration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2022Vibration; Vibration

  IT WAS REPORTED THAT DURING THE PATIENT'S FOURTH EXTENDED TROCHANTERIC OSTEOTOMY (ETO) SURGICAL PROCEDURE, THE SURGEON EXPERIENCED VIBRATION WHILE USING THE EZOUT BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SCIATIC NERVE PALSY. THE SURGEON INDICATES THAT THE PATIENT IS RECOVERING.

  Patient problems: Nerve Damage

  MAUDE report 13902089 ↗