BEUDAMED
    FDA Enforcement Class II Ongoing

    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

    Recall: Z-1565-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1565-2022
    Event ID
    90679
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nobel Biocare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    July 25, 2022
    Classification Date
    August 23, 2022
    Address
    Vastra Hamngatan 1, Goteborg, N/A, Sweden

    Description

    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

    Reason

    Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

    Code Info

    Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227

    Distribution

    U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden

    Quantity

    347 devices