Recall Z-1008-2024— Brasseler USA I Lp
Class II · Ongoing
Class II FDA medical device recall by Brasseler USA I Lp, initiated 2024-01-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Brasseler USA I Lp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-11
- Firm location
- Savannah, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.