Brasseler 8S RA SHP RD recall
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Why was Brasseler 8S RA SHP RD recalled?
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
- Product
- Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
- Recalling firm
- Brasseler USA I Lp
- 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.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)