NA 2296101421Recalls & reported problems
Stryker Corporation · 2.1mm Cross-Cut Fissure Round Tip Carbide Bur · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540046277), received between Jun 19, 2019 and Jun 19, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Vibration” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Vibration3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2019Vibration; Vibration
IT WAS REPORTED THAT DURING A PROCEDURE ON THE WISDOM TOOTH, THREE BURS MADE NOISE AND WAS MOVING. IT WAS ALSO REPORTED THAT THERE WAS A FORTY-FIVE MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE THIRD BUR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8711803 ↗MalfunctionJun 19, 2019Vibration; Vibration
IT WAS REPORTED THAT DURING A PROCEDURE ON THE WISDOM TOOTH, THREE BURS MADE NOISE AND WAS MOVING. IT WAS ALSO REPORTED THAT THERE WAS A FORTY-FIVE MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BUR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8711802 ↗MalfunctionJun 19, 2019Vibration; Vibration
IT WAS REPORTED THAT DURING A PROCEDURE ON THE WISDOM TOOTH, THREE BURS MADE NOISE AND WAS MOVING. IT WAS ALSO REPORTED THAT THERE WAS A FORTY-FIVE MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BUR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8711800 ↗
Other BUR, DENTAL devices
- Brasseler USA 001156T0Peter Brasseler Holdings, LLC · BUR, DENTAL1 recall0 reports
- TC cavity burs cone square E013834101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL7 reports
- NA 1607002107Stryker Corporation · BUR, DENTAL3 reports
- TC cavity Burs Round E012334101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL3 reports
- NA 2296100212Stryker Corporation · BUR, DENTAL2 reports
- NA 1607002105Stryker Corporation · BUR, DENTAL2 reports
- Zekrya® E014924101600MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- TC cavity Burs Round E012324101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.