BEUDAMED
    FDA Recall Terminated

    NPr FCZImp Crwn ASC CC RP CAD 1-25s3 - 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 · Initiated March 29, 2021

    Recall

    Recall Number
    Z-1678-2021
    Event Number
    87848
    Firm
    Nobel Biocare Procera LLC
    FEI Number
    3005031178
    Product Code
    NHA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 29, 2021
    Terminated
    September 1, 2021
    Address
    800 Corporate Dr, Mahwah, NJ, 07430-2011

    Description

    NPr FCZImp Crwn ASC CC RP CAD 1-25s3 - 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

    Action

    Nobel Dental notified US customers via phone by North American Customer Service on 3/29/21 and informed which device[s] was affected and that the device[s] had not been processed properly. Email communication was also distributed with a return label. Please find attached the return label for order XXXX to be returned to our manufacturing facility. We sincerely apologize for the inconvenience that this delay has caused. With the new order we are taking all possible actions to have it to you as soon as possible, while still ensuring the premium quality that you expect. The EMEA customer service/sales representatives were contacted by North America Customer Service.

    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