ProTaper Gold Rotary File PTGRS221Recalls & reported problems
Tulsa Dental Products LLC · ProTaper Gold Rotary S2 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI D716PTGRS2211), received between Jul 12, 2023 and Apr 13, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 10 most recent of 10 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 S2 21MM FILE BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853992 ↗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 24820683 ↗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 24820613 ↗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 24820263 ↗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 24820148 ↗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 24818862 ↗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 24818831 ↗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 24818718 ↗MalfunctionApr 21, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT 2 PROTAPER GOLD ROTARY S2 21MM BROKE DURING USE IN THE SAME PATIENT. THE BROKEN PARTS COULD NOT BE RETRIEVED AND THEY WERE INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21871476 ↗MalfunctionJul 12, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT PROTAPER GOLD S2 21MM STER BROKE DURING USE. THE BROKEN PARTS REMAIN IN THE ROOT CANAL. IT IS REPORTED THAT AT THIS TIME NO TREATMENT BUT FURTHER TREATMENT MAY BE REQUIRED IF PATIENT EXPERIENCES ANY PAIN AT SOME POINT; ROOT TIP RESECTION MIGHT BE NECESSARY IF NEEDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17306640 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
- WaveOne Gold Rotary File WGPRIME25Tulsa Dental Products LLC · FILE, PULP CANAL, ENDODONTIC68 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page