ProTaper Gold Rotary File PTGRF121Recalls & reported problems
Tulsa Dental Products LLC · ProTaper Gold Rotary F1 21mm · Class 1
All models of ProTaper Gold Rotary File (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI D716PTGRF1211), received between Aug 26, 2024 and Apr 13, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- Device Embedded In Tissue or Plaque4
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853982 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853964 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY F1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853962 ↗MalfunctionSep 11, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER FIN.21MM/F1 FILE BROKE DURING USE. THE BROKEN PART HAS NOT BEEN RETRIEVED. REPORTEDLY, NO INJURY. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23025090 ↗MalfunctionMar 24, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER FIN.21MM/F1 *NOT CE* BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. IF THE ROOT TIP IS ABSORBED 2MM BELOW THE BROKEN FILE, THE TOOTH WILL BE EXTRACTED. REQUESTED FURTHER INFORMATION. REPORTEDLY, NO INJURY AT THIS TIME.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21677724 ↗MalfunctionDec 30, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD F1 21MM STER FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. THERE IS A RISK OF TOOTH EXTRACTION IN A LATER STAGE. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21034825 ↗MalfunctionAug 26, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER FIN.21MM/F1 FILE BROKE DURING USE. THE BROKEN PART CANNOT BE RETRIEVED. DOCTOR RECOMMENDED THAT PATIENT GO TO HOSPITAL TO REMOVE BROKEN PART, PATIENT VOLUNTARILY CHOSE TO MONITOR. REPORTEDLY, TWO DAYS LATER PATIENT EXPERIENCED PAIN IN THE ROOT TIP AREA AND PAIN WHILE CHEWING. APPOINTMENT MADE FOR EXTRACTION OF TOOTH. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20064611 ↗
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- EdgeOne Fire SEOFAST21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7300625RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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