Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Summary
The FDA issued a Class II for Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide de by Brasseler USA I Lp. Reason: The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece..
Details
Source
Device Recall
External ID
Z-1008-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Lot/Code Info: Lot numbers L01G6 and L16P9, UDI-DI 00887919188483, RX.
Quantity Affected: 440 burs
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-11
Company
Savannah, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Brasseler USA I Lp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Brasseler USA I Lp have FDA actions?
This is the only FDA action we have on record for Brasseler USA I Lp in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1008-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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