FDA recall Z-1008-2024

Brasseler USA I Lp · Class II · device

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2024-01-11
Report date
2024-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Savannah, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2024