Events

Safety Alert for Adapters, Handpieces, ITI Dental Implant System with Instruments: (1) Extra Short, (2) Short. Catalog No.: (1) 046,470, (2) 046,471; Lot No: 1200

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by The Streumann Co; Institut Straumann AG.

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
    392
  • Date
    2002-02-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The handpiece adapter of the dental instrument above may fail or snap, sometimes requiring high rotation. the dealer initiated a correction by letter dated december 7, 2001.
  • Action
    Make sure you have received from Straumann USA the letter dated December 7, 2001, return package and Federal Express prepaid airfare. Identify and isolate any affected product in your inventory. Return the affected product to Straumann USA using Federal Express prepaid airfare and return package. Srtaumann USA will replace the affected product immediately upon receipt. For more information, contact your local Straumann representative. . For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Adapters, Handpieces, ITI Dental Implant System with Instruments: (1) Extra Short, (2) Short. Cat...

Manufacturer

The Streumann Co; Institut Straumann AG