K-file hand instrument KFS01025Recalls & reported problems
Tulsa Dental Products LLC · K FILE: 010 25MM LEXICON STERILIZED · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 D716KFS010251), received between May 21, 2024 and May 21, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Device Embedded In Tissue or Plaque2
- Tooth Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT K FILE: 010 25MM LEXICON STERILIZED FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND THE PATIENT WAS GIVEN THE CHOICE TO REFERRED TO SPECIALIST BUT CHOSE TO HAVE THE TOOTH REMOVED. CASE 3 OF 3.
Patient problems: Tooth Loss
MAUDE report 19359863 ↗MalfunctionMay 21, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT K FILE: 010 25MM LEXICON STERILIZED FILE BROKE DURING USE. PATIENT WAS REFERRED TO SPECIALIST WHO COMPLETED THE PROCEDURE. THE BROKEN PART COULD NO BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY. CASE 2 OF 3.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19359654 ↗MalfunctionMay 21, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT K FILE: 010 25MM LEXICON STERILIZED FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.CASE 1 OF 3.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19359574 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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