Events

Safety Alert for LUPINE LOOP WITH ORTHOCORD ANCHOR SYSTEM - Registration 80145900903 - Affected lots: all numbers below 3571653 of the product codes lupine: 201704, 210705, 210707, 210708, 210709, 210710, 210711, 210712, 222980 and 222981.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1114
  • Date
    2012-02-15
  • 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
    The problem was identified during internal investigation upon receipt of a customer complaint in the United States. There are no records in the National Notification System - NOTIVISA. Anvisa follows this Field Action.
  • Reason
    The batches identified may have been assembled with a wrong suture configuration.
  • Action
    To users and professionals, 1) Discontinue use of the product; 2) Identify the affected product in your inventory; 2) Segregate it; 3) Fill out the Return Form. This form should be used to indicate the condition of your inventory of affected products. Fill out the business response form and fax back 1130301187, including a copy of this form with the product being returned.

Device

LUPINE LOOP WITH ORTHOCORD ANCHOR SYSTEM - Registration 80145900903 - Affected lots: all numbers ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.