BEUDAMED
    FDA Recall Terminated

    RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.

    Recall: Z-1110-2017 · Initiated December 2, 2016

    Recall

    Recall Number
    Z-1110-2017
    Event Number
    76319
    FEI Number
    3007702492
    Product Code
    NPL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 2, 2016
    Posted
    January 27, 2017
    Terminated
    May 5, 2017
    Address
    Biom'up Batiment 7 8 allee Irene Joliot Curie St Priest France

    Description

    RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.

    Reason

    Lack of sterility assurance

    Action

    An Urgent Medical Device Recall letter was mailed to affected customer on 12/02/2016 to inform them of the recall. The reason and actions to be taken were explained in the letter. Customer was asked to examine their inventory and contact Biom'Up to arrange for return of product.

    Distribution

    Distributed to a sole distributor in NC.

    Quantity

    1,682 units