Class 3 Device Recall Denticator

• Date Initiated by Firm: December 05, 2022
• Date Posted: December 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0725-2023
• Recall Event ID: 91173
• Product Classification: Pick, massaging - Product Code JET
• Product: Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
• Code Information: Lot 203257. Recall expanded on 12/19/2022 to include lot 207959
• Recalling Firm/ Manufacturer: Young Dental Manufacturing I, LLC; 13705 Shoreline Ct E; Earth City MO 63045-1202
• For Additional Information Contact: Mr. Jose Espino; 224-622-7191
• Manufacturer Reason for Recall: mislabeled product
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.