Z-0725-2023Class III
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
Young Dental Manufacturing Co 1, LLC. / initiated 2022-12-05 / Open, Classified / root cause: manufacturing process
Young Dental Manufacturing I, LLC began a recall of Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 on . FDA classified it as Class III and gives the reason as "mislabeled product". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0725-2023
- Classification
- Class III
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Young Dental Manufacturing Co 1, LLC.
- Product
- Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
- Product code
- JET Pick, Massaging
- Reason for recall
- mislabeled product
- Root cause tag
- manufacturing process
- FDA root cause
- Employee error
- Action
- The firm issued an URGENT: MEDICAL DEVICE RECALL notice on 12/05/2022 to its consignees be certified mail. The notice explains the issue and requests either the return or discarding of the affected product. The response form indicates that their customers will be notified. On 12/19/2022, firm expanded recall to include an additional affected lot. Customers were sent an updated URGENT: MEDICAL DEVICE RECALL notice on 12/19/2022, which included the same instructions.
- Quantity in commerce
- 600 packs
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.
- Product codes and lots
- Lot 203257. Recall expanded on 12/19/2022 to include lot 207959
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0725-2023 | Class III | Ongoing | Voluntary: Firm initiated |
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