Bur, Dental
FDA adverse event reports and recall history for bur, dental (product code EJL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 520
- Deaths
- 0
- Injuries
- 147
- Malfunctions
- 354
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-03-21Open, ClassifiedProcess control
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
The hardness not meeting the material specification and may cause the diamond bur to bend.
- 2024-02-07Open, ClassifiedUnder Investigation by firm
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
- 2020-01-30TerminatedUnder Investigation by firm
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
- 2018-05-14TerminatedUnder Investigation by firm
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
The products are labeled with an incorrect product number.
- 2009-09-08TerminatedProcess control
BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm system. The drill is etched and labe
- Open, ClassifiedUnder Investigation by firm
Alpen Clinic 100 Carbide Instruments (R100057C)
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
- Open, ClassifiedUnder Investigation by firm
FG 57 100057X (100057X)
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
- Open, ClassifiedUnder Investigation by firm
Clinic Pack 100 Pieces FG 57 100057C (100057C)
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
- Open, ClassifiedUnder Investigation by firm
CEI Cutting Edge Instruments (PTC-57C)
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
- Open, ClassifiedUnder Investigation by firm
Strauss 25 Carbide Dental Burs (100057XXV)
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
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