Events

Recall Or Safety Alert for Surgical nets: Ethicon Physiomesh Flexible Composite Mesh composite flexible mesh

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Johnson & Johnson International (Johnson & Johnson Medical GmbH plant in Germany), BELGIUM.

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
    Recall / Safety alert
  • Event Number
    ИМ-7.100844
  • Date
    2016-06-28
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 recall data from the U.S. and Belarus.
  • Extra notes in the data
  • Reason
    The manufacturer, on its own initiative, decided to implement a voluntary global recall from the medical device market. the reason for the global recall from the market was the analysis of unpublished data, carried out at the request of the ethicon medical safety team by two independent registries in the field of hernia treatment (the german herniamed registry and the danish hernia database dhdb). the rate of relapses / reoperations after laparoscopic surgery to remove ventral hernias using medical devices was higher than the average recurrence rate among patients in these registers.

Device

Surgical nets: Ethicon Physiomesh Flexible Composite Mesh composite flexible mesh

Manufacturer

Johnson & Johnson International (Johnson & Johnson Medical GmbH plant in Germany), BELGIUM