SilCut 459152Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551164815), received between May 27, 2025 and Feb 19, 2026 — 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 16, 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.

• MalfunctionFeb 19, 2026Product Quality Problem

  IT WAS REPORTED DURING A MEDICAL PROCEDURE THE UNIT WAS NOT CUTTING THROUGH/PULLING TISSUE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24388157 ↗
• MalfunctionMay 27, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DOWN BITERS WERE FOUND BROKEN AFTER MINIMAL USE, DESPITE NOT BEING USED ON EXCESSIVELY HARD BONE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087089 ↗