WaveOne Gold Rotary File WGPRIME31Recalls & reported problems
Tulsa Dental Products LLC · WaveOne Gold Reciprocating File Primary 31mm · Class 1
All models of WaveOne Gold Rotary File (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D716WGPRIME311), received between Dec 12, 2023 and Aug 11, 2025 — classified as 1 injury, 1 malfunction.
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. 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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 31MM FILE BROKE DURING USE. THE BROKEN PART HAS NOT BEEN RETRIEVED AND APPOINTMENT IS SCHEDULED FOR FURTHER REMOVAL/TREATMENT. NO INJURY REPORTED. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 22770365 ↗MalfunctionDec 12, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD RECIPROCATING FILE PRIMARY 31MM BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18311436 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
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- EdgeTaper Platinum SETS125HTUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500421US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF321US 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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