Endodontic Hand Instruments 6701021Recalls & reported problems
Tulsa Dental Products LLC · C+ FILE READY•STEEL 21MM 010 · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D71667010211), received between May 27, 2025 and Jun 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Device Embedded In Tissue or Plaque1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 21 MM 010 FILE BROKE DURING USE. THE TIP OF THE FILE BROKE AND IS CAUSING PAIN TO THE PATIENT. THE BROKEN PART WAS WASHED BY ROOT CANAL TREATMENT EQUIPMENT, AND A TOOTH X-RAY WAS TAKEN, WHICH SHOWED THAT IT WAS NOT IN THE ROOT CANAL.
Patient problems: Pain
MAUDE report 22193089 ↗MalfunctionMay 27, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 21MM 010 FILE BROKE DURING USE. AFTER THE CASE, THE DOCTOR'S PRIMARY TREATMENT: INFORM THE PATIENT OF THE CURRENT SITUATION, AND TREAT IT AS APPROPRIATE BASED ON THE CONDITION OF THE TOOTH. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22086739 ↗
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- Edge File SX7200621RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.