Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs...
FDA Recall #Z-1008-2024 — Class II — January 11, 2024
Product Description
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.
Recalling Firm
Brasseler USA I Lp — Savannah, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
440 burs
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.
Code Information
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated