Endodontic Hand Instruments 6700825Recalls & reported problems
Tulsa Dental Products LLC · C+ FILE READY•STEEL 25MM 008 · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D71667008251), received between Jan 4, 2024 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
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 25MM 008 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 24496876 ↗MalfunctionJun 19, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 25MM 008 BROKE DURING USE. THE BROKEN PART IS IN THE APICAL THIRD OF ROOT CANAL AND COULD NOT BE RETRIEVED. IF THERE IS ANY SYMPTOMS AN APICAL SURGERY WILL BE DONE. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19566479 ↗MalfunctionJan 4, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT C+FILE READYSTEEL 25MM 008 FILE BROKE DURING USE. THE OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18444566 ↗
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- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026664U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7200621RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFPRI21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350431US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.