Integra® Miltex® 4-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780063544), received between Feb 2, 2026 and Feb 19, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Break

  PATIENT FOUR OF THE REPORTED EVENTS- A FACILITY REPORTED THAT DURING AN IMPACTED WISDOM TEETH SURGICAL REMOVAL, THE CARBON SURGICAL BLADES 15 (4-115) FRACTURED INSIDE A PATIENT'S MOUTH, BREAKING DIRECTLY AT THE CUTTING SURFACE, AND IS CONCERNED FOR THE OPERATOR AND PRESENTS A SIGNIFICANT RISK OF PATIENT INJURY, AND HAD EXPERIENCED THIS ISSUE ON FIVE DIFFERENT OCCASIONS OVER THE LAST SIX MONTHS. ALL BROKEN PIECES WERE RETRIEVED FROM THE MOUTH USING A SURGICAL SNAP INSTRUMENT. THERE WAS NO REPORT OF PATIENT INJURIES OR DEATH, BUT A MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392203 ↗
• MalfunctionFeb 19, 2026Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388177 ↗
• MalfunctionFeb 18, 2026Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384369 ↗
• MalfunctionFeb 18, 2026Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384238 ↗
• MalfunctionFeb 12, 2026Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324826 ↗
• MalfunctionFeb 2, 2026Break

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240661 ↗