Events

Safety Alert for Trade name: INSTRUMENTAL FOR STRYKER KNEE ARTROPLASTY /// Technical name: Surgical instruments /// ANVISA registration number: 80005430207 Hazard class: I - Low Risk Model affected: CLAMP PATELAR 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
    2004
  • Date
    2016-08-11
  • 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
    - Segregate the product - Return to the company holding the registration
  • Reason
    The components of the apparatus, including pins and tightening subcomponents, can potentially dissociate and fall into the wound intraoperatively, requiring reoperation.
  • Action
    Field Action Code RA 2016-098 triggered under the responsibility of the company Stryker do Brasil Ltda. Company is performing product recall.

Device

Trade name: INSTRUMENTAL FOR STRYKER KNEE ARTROPLASTY /// Technical name: Surgical instruments //...

Manufacturer

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