NA 1608006137Recalls & reported problems
Stryker Corporation · 4.0mm Round Fast Cutting Bur · Class 1
- 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 04546540030733), received between Oct 30, 2019 and Dec 9, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device1
- Packaging Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Burn(s)1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2025Overheating of Device; Overheating of Device
MalfunctionOct 30, 2019Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE, IT WAS NOTED DURING VISUAL INSPECTION. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9258227 ↗
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- NA 1607002107Stryker Corporation · BUR, DENTAL3 reports
- NA 2296101421Stryker 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.