Events

Recall of Device Recall RENOVIX Guided Healing Collagen Membrane

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biom'up.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76319
  • Event Risk Class
    Class 2
  • Event Number
    Z-1110-2017
  • Event Initiated Date
    2016-12-02
  • Event Date Posted
    2017-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152768
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Barrier, animal source, intraoral - Product Code NPL
  • 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.

Device

Device Recall RENOVIX Guided Healing Collagen Membrane
  • Model / Serial
    Lot Numbers: MCG16003.133034 MCG16003.133035 MCG16003.133036 MCG16003.133037 MCG16003.133038 MCG16003.133172 MCG16003.133173 MCG16003.133174 MCG16003.133251 MCG16003.133252 MCG16003.133253 MCG16003.133254
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to a sole distributor in NC.
  • Product Description
    RENOVIX Guided Healing Collagen Membrane || Intended for use in oral surgical procedures.
  • Manufacturer
    Biom'up

Manufacturer

Biom'up
  • Manufacturer Address
    Biom'up, Batiment 7, 8 allee Irene Joliot Curie, St Priest France
  • Manufacturer Parent Company (2017)
    Biom' Up
  • Source
    USFDA