Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-0725-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0725-2023Class IIIOngoingVoluntary: Firm initiated