ProTaper Universal Hand Files PTUHSX19Recalls & reported problems
Tulsa Dental Products LLC · ProTaper U Hand SX 19mm · 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 D716PTUHSX191), received between Jun 4, 2025 and Nov 4, 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 Plaque2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER SHAP. 19MM/SX NOT CE FILE BROKE DURING USE. THE BROKEN PART REMAINS IN CANAL. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 23462502 ↗MalfunctionJun 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER H-U 19 MM/SX *NOT CE* FILE BROKE DURING USE. THE INSTRUMENT SEPARATED AND ABOUT 15 MM OF BROKEN TIP WAS LEFT IN THE CANAL. THE NEXT DAY THE PATIENT WAS SEEN AT SPECIALIST HOSPITAL TO REMOVE THE BROKEN PART UNDER MICROSCOPE. THE OUTCOME OF THE EVENT I NOT KNOWN AS OF THIS MDR, FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22142520 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.