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.

Recalled February 14, 2024 · FDA recall Z-1008-2024 · Brasseler USA I

Hazard

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

Units

440 burs

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Brasseler USA I Lp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →