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

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

Code information: Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.

Distribution pattern: 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.