Zekrya® E014924101600 (REF E015134100000)Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Dental burs · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI J003E0151341000001), received between Nov 6, 2023 and Dec 29, 2025 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARB.B.SURGERY ZEKRYA FG 23MM BUR BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23907248 ↗MalfunctionNov 6, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT CARB.B.SURGERY ZEKRYA FG 28MM BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18073158 ↗
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
- 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
- TC cavity Burs Round E012324101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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