Recall Z-0725-2023 ยท JET Pick, Massaging
Young Dental Manufacturing I, LLC
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
| Date | Dec 19, 2022 (initiated Dec 5, 2022) |
| Status | Open, Classified |
| Reason | mislabeled product |
| 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 | 600 packs |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.