Z-1008-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- January 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 440 burs
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.
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.
Code Information
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.