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 L16P9UDI-DI 00887919188483RX
- 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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