FDA Enforcement
Class III
Ongoing
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Recall: Z-0725-2023
·
Reported December 28, 2022
Enforcement
- Recall Number
- Z-0725-2023
- Event ID
- 91173
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Young Dental Manufacturing I, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 28, 2022
- Initiation Date
- December 5, 2022
- Classification Date
- December 19, 2022
- Address
- 13705 Shoreline Ct E, Earth City, MO, 63045-1202, United States
Description
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Reason
mislabeled product
Code Info
Lot 203257. Recall expanded on 12/19/2022 to include lot 207959
Distribution
Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.
Quantity
600 packs