Events

Safety Alert for Technical Name: MINIMALLY INVASIVE INSTRUMENTAL SYSTEM AT ATQ ANVISA Registration Number: 80005430165 Hazard Class: I Affected Model: STRAWBERRY DOOR Affected serial numbers: T6318

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Stryker do Brasil Ltda; Stryker Orthopaedics.

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
    2188
  • Date
    2016-12-13
  • 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 IFU shall be replaced by the current revision and provided by Stryker together with notification of this field action.
  • Reason
    The current ifu has non-efficient sterilization parameters.
  • Action
    Field Action Code RA 2016-136 triggered under the responsibility of the company Stryker do Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Technical Name: MINIMALLY INVASIVE INSTRUMENTAL SYSTEM AT ATQ ANVISA Registration Number: 8000543...

Manufacturer

Stryker do Brasil Ltda; Stryker Orthopaedics
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA