BEUDAMED
    FDA Enforcement Class II Terminated

    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.

    Recall: Z-0053-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0053-2021
    Event ID
    86432
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    August 31, 2020
    Classification Date
    October 2, 2020
    Termination Date
    October 18, 2021
    Address
    505 W 10200 S, N/A, South Jordan, UT, 84095-3800, United States

    Description

    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.

    Reason

    Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

    Code Info

    Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.

    Quantity

    412 syringes (206 kits)