Reported Feb 14, 2024 · Ongoing

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

Brasseler USA I LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Brasseler USA I Lp · 1 Brasseler Blvd · Savannah, GA · 31419-9576

Is this the product you have?

  • Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Lot codes and dates
    • Lot numbers L01G6 and L16P9
    • UDI-DI 00887919188483
    • RX
Amount recalled
440 burs

Where it was sold

Why it was recalled

The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

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