ProTaper Gold Rotary File PTGRS121Recalls & reported problems
Tulsa Dental Products LLC · ProTaper Gold Rotary S1 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D716PTGRS1211), received between Jun 19, 2024 and Apr 13, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 6 most recent of 6 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 S1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854041 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854012 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S1 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854010 ↗MalfunctionApr 8, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S2 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820853 ↗MalfunctionApr 8, 2026Break
IN THIS EVENT IT IS REPORTED THAT A PROTAPER GOLD ROTARY S2 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820721 ↗MalfunctionJun 19, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER GOLD S1 21MM STER FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19566564 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
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- EdgeTaper SETF225US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall1 report
- Brasseler USA 5026670U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026667U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- 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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