Events

Safety Alert for Injectable synthetic bone substitute Jectos -. Registration No. 80240590014 -. Model: J406C05 -. Lot: 406/13204

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ORTECH MEDICAL COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO LTDA..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1308
  • Date
    2013-09-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Product made by the company KASIOS - 18, CHEMIN DE LA VIOLETTE - 31240 L UNION - FRANCE
  • Reason
    Packaging open and without signals being sealed: a customer reported to the company that one of the products had the packaging of the solid and liquid phases (plastic bag) open and with no signs of being sealed.
  • Action
    The company is communicating its customers (Annex) aiming at the safety of users of the product and making the collection of the remaining units of the lot in question. According to the company, in the instructions for use of the product, it is stated that the integrity of the packaging must be checked before use. This information is intended to avoid the use of a product that is unfit for use and requires its disposal. The user's instructions therefore state that the product can not be resterilized. These two information minimizes the risk of the user using a product that may have been contaminated by discontinuity of the sterilization to which it was subjected during the manufacturing process. ## UPDATE: Field Action completed by the company.

Device

Injectable synthetic bone substitute Jectos -. Registration No. 80240590014 -. Model: J406C05 -. ...

Manufacturer

ORTECH MEDICAL COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO LTDA.
  • Source
    ANVSANVISA