BEUDAMED
    FDA Enforcement Class II Terminated

    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

    Recall: Z-2207-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2207-2020
    Event ID
    85331
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Usa Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2020
    Initiation Date
    July 19, 2019
    Classification Date
    June 2, 2020
    Termination Date
    October 27, 2020
    Address
    22715 Savi Ranch Pkwy, N/A, Yorba Linda, CA, 92887-4609, United States

    Description

    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

    Reason

    The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

    Code Info

    Lot number: 13080792

    Distribution

    US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None

    Quantity

    221 implants