Class II

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

Brasseler USA I Lp · January 11, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

440 burs

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1008-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Brasseler USA I Lp Medical Device Recall: Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx. | SafeCheck