FDA Enforcement
Class II
Ongoing
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Recall: Z-1008-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-1008-2024
- Event ID
- 93809
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Brasseler USA I Lp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- January 11, 2024
- Classification Date
- February 7, 2024
- Address
- 1 Brasseler Blvd, Savannah, GA, 31419-9576, United States
Description
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 Info
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
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.
Quantity
440 burs