Safety Alert for Trade name: TRIDENTE CERÂMICA /// Technical name: QUADRIL ARTHROPLASTIC SYSTEM /// ANVISA registration number: 80005430060 /// Risk class: III - High risk /// Model: ACETABULO LEVER /// Serial numbers affected: See Distribution map

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
    2000
  • Date
    2016-10-03
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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 product must be segregated and returned to Stryker do Brasil.
  • Reason
    There is a potential risk of the impactor passing through the acetabulum, thus causing a gradual overhang of the thread over time.
  • Action
    Field Action Code RA 2016-107 triggered under the responsibility of the company Stryker do Brasil Ltda. Company is performing product recall.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    ANVSANVISA