EXACTTAPER UTTHF325Recalls & reported problems
Ss White Burs, Inc. · EXACTTAPERH ROTARY FILE F3 25 MM - 6 PACK · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D690TTHF3252), received between Sep 11, 2025 and Sep 11, 2025 — classified as 1 injury.
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
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
DURING A DENTAL PROCEDURE ON (B)(6) 2025, AN ENDODONTIC FILE BROKE ON INITIAL INSERTION OF FILE. THE FILE BROKE OFF ABOVE THE CUTTING FLUTE WHICH RESULTED IN THE FILE REMAINING IN THE PATIENTS TOOTH. SS WHITE BURS WAS MADE AWARE OF THIS INCIDENT ON (B)(6) 2025.
Patient problems: Foreign Body In Patient
MAUDE report 23025753 ↗
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- Edge File SX7200621RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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