BEUDAMED
    FDA Recall Terminated

    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution.

    Recall: Z-0053-2021 · Initiated August 31, 2020

    Recall

    Recall Number
    Z-0053-2021
    Event Number
    86432
    Firm
    Ultradent Products, Inc.
    FEI Number
    1718912
    Product Code
    EBF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 31, 2020
    Terminated
    October 18, 2021
    Address
    505 W 10200 S, South Jordan, UT, 84095-3800

    Description

    PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution.

    Reason

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

    Action

    On August 31, 2020, the firm sent an URGENT FIRST NOTICE PRODUCT RECALL" notification to US customers via UPS (International customer via email on September 1, 2020) informing them of the potential product contamination that may affect the performance characteristics of the product to include, micro-hardness, bond strength, and wear and may pose an increased risk of restoration failure. Customers are instructed to discontinue use of the product immediately. Customers are also instructed to: -Complete the Return Response Form enclosed with this letter and Fax 801-553-4609 or email to [email protected]. -Using the supplied shipping labels, return to Ultradent the completed form and all unused Product; and -Maintain a ledger of the patients treated with the Product, including the patients name and applicable treatment information. The Recalling Firm will send out replacement kits and issue an $100 credit to customer's accounts For questions regarding replacement product, contact Customer Service at 1-888-230-1420. For any questions regarding the recall, contact Customer Concerns at 801-553-4139.

    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)