Brasseler USA I Lp recalls Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
- Recall date
- January 11, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1008-2024
- FDA classification
- Class II
- Brand / firm
- Brasseler USA I Lp
- Sold / distributed
- 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.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Get recall alerts
Free email alert whenever Brasseler USA I Lp has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Brasseler USA I Lp