Events

Safety Alert for VICRYL Absorbable Surgical Suture

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ethicon S.A. || Johnson & Johnson International || Johnson & Johnson Medical Gmbh- || Ethicon Llc || Johnson & Johnson de Brasil Industria y Comercio Productos || para la Salud Ltda || Johnson & Johnson Industrial Ltda || Ethicon Sarl.

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
    R1505-194
  • Event Number
    2007DM-0000908-R2
  • Date
    2015-05-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=181
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that these lots should contain references to braided sutures, however they may contain monofilament sutures, and warns that the use of a monofilament suture such as a braided suture may influence how the tissue is handled, the characteristics of the nodes and the tension of the suture. closure of tissue, leading to potential adverse events on patients.

Device

VICRYL Absorbable Surgical Suture

Manufacturer

Ethicon S.A. || Johnson & Johnson International || Johnson & Johnson Medical Gmbh- || Ethicon Llc...