Endodontic Hand Instruments 6700625Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D71667006251), received between Jul 9, 2025 and Mar 3, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 25 MM 006 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496958 ↗
• MalfunctionNov 4, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 25MM 006 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464445 ↗
• MalfunctionJul 9, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 25MM 006 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. PATIENT REPORTED NO DISCOMFORT; NO SPECIAL TREATMENT WAS PERFORMED. PATIENT ASKED TO REPORT AND DISCOMFORT AND TO FOLLOW UP. NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22459560 ↗