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Recall Observatory FDA recall evidence

Device product

Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

Z-0725-2023

December 05, 2022

Class III

Product summary

Firm
Young Dental Manufacturing I, LLC
Event
Event 91173
Status
Ongoing
Classification
Class III
Quantity
600 packs
Official record key
device-enforcement:Z-0725-2023

Official wording

Reason: mislabeled product

Code information: Lot 203257. Recall expanded on 12/19/2022 to include lot 207959

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled