Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Summary
The FDA issued a Class III for Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 by Young Dental Manufacturing I, LLC. Reason: mislabeled product.
Details
Source
Device Recall
External ID
Z-0725-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Lot/Code Info: Lot 203257. Recall expanded on 12/19/2022 to include lot 207959
Quantity Affected: 600 packs
Reason for Recall
mislabeled product
Distribution
Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-05
Company
Earth City, MO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 404 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Young Dental Manufacturing I, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Young Dental Manufacturing I, LLC have FDA actions?
Young Dental Manufacturing I, LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0725-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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