Endodontic Hand Instruments 670AS21Recalls & reported problems
Tulsa Dental Products LLC · C+ FILE READY•STEEL 21MM ASSORTED · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D716670AS211), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 21MM ASS BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19069513 ↗
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- 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.