ProTaper Universal Hand Files PTUHF121Recalls & reported problems
Tulsa Dental Products LLC · ProTaper U Hand F1 21mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI D716PTUHF1211), received between Oct 16, 2024 and Jul 15, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- Device Embedded In Tissue or Plaque3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER H-U 21MM/F1 BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22505413 ↗MalfunctionApr 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER H-U 21MM/F1 -NOT CE- RUBBER HANDLE SEPARATED FROM THE FILE. THE FILE HAD TO BE EXTRACTED BY FORCEPS. FURTHER INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926079 ↗MalfunctionOct 31, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER FIN.21MM/F1 *NOT CE* FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE REMOVED. FURTHER TREATMENT IS AN OPTION, IT WAS SUGGESTED TO THE PATIENT TO SEE A SPECIALIST TO REMOVE THE BROKEN PART AND UNDERGO THE ROOT CANAL TREATMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20577133 ↗InjuryOct 16, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER FIN.21MM/F1 *NOT CE* BROKE DURING USE. THE BROKEN PART HAS NOT BEEN RETRIEVED. WITH SIGNIFICANT RESORPTION AND LOOSENING OF THE PATIENT'S ALVEOLAR BONE, TOOTH EXTRACTION IS REQUIRED. RECEIVED UPDATE INFORMATION BEFORE THE SUBMISSION OF THE INITIAL MDR; THE BROKEN FILE HAS BEEN REMOVED AND DESTROYED, NO RETURN OF FILE. DUE TO PATIENT'S DENTAL ISSUES THE DOCTOR RECOMMENDED TOOTH EXTRACTION. CURRENTLY THE PATIENT HAS NO TOOTHACHE SYMPTOMS AND IS FINE.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 20463054 ↗
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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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