Events

Safety Alert for Trade Name: Screws for Large and Small Fragments ///// Model: 1.36.28.03.19.012; 1.36.28.03.19.014; 1.36.28.03.19.016; 1.36.28.03.19.018; 1.36.28.03.19.020; 1.36.28.03. 19.022; 1.36.28.03.19.024; 1.36.28.03.19.026; 1.36.28.03.19.028 and 1.36.28.03.19.030 //// Registry: 80084420014.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by TORIDE IND. COM. 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
    1886
  • Date
    2016-04-18
  • 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
    AT.
  • Reason
    Company toride ind. with. ltda identified that the product screws for large and small fragments were left with the wrong registration number on the lot label: i00417 / 025226; i00417 / 025444; i00417 / 025697; i00417 / 026018; i00417 / 025228; i00417 / 025446; i00417 / 025699; i00417 / 025229; i00417 / 025447; i00417 / 025700; i00417 / 025231; i00417 / 025449; i00417 / 025702; i00417 / 025234; i00417 / 025452; i00417 / 025705; i00417 / 025232; i00417 / 025450; i00417 / 025703; i00417 / 025227; i00417 / 025445; i00417 / 025698; i00417 / 025230; i00417 / 025448; i00417 / 025701; i00417 / 025231; i00417 / 025449; i00417 / 025702.
  • Action
    Action code 073/2016. Sending letter to clients /// Gathering.

Device

Trade Name: Screws for Large and Small Fragments ///// Model: 1.36.28.03.19.012; 1.36.28.03.19.01...

Manufacturer

TORIDE IND. COM. LTDA.
  • Source
    ANVSANVISA