FDAFDA · Food and drugs·Recall number Z-1008-2024
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Published February 14, 2024 · Recall initiated: January 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Brasseler USA I Lp
- Distributor
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.
- Lot
- Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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