BEUDAMED
    FDA Enforcement Class II Terminated

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

    Recall: Z-1678-2021 · Reported June 2, 2021

    Enforcement

    Recall Number
    Z-1678-2021
    Event ID
    87848
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nobel Biocare Procera LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 2, 2021
    Initiation Date
    March 29, 2021
    Classification Date
    May 25, 2021
    Termination Date
    September 1, 2021
    Address
    800 Corporate Dr, N/A, Mahwah, NJ, 07430-2011, United States

    Description

    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

    Reason

    Not manufactured to specification

    Code Info

    Serial Numbers: 173939852, 173940027, 173940107, 173940346, 173940844, 173940852, 173942662

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.

    Quantity

    7 units