Events

Safety Alert for INSTRUMENTAL FOR STRINGS TS STRYKER TRAUMA, Wire Guide, register 80005430088, risk class I, lots / series: K076CCF; K0AF3C9; K0B8538; K07B727; K785079; K610172; K03FE02; K043C6B; K07EF49; K083C1D; K0DE2EC; K889978; K140480; K282163; K487845 and K261793

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 Trauma GmbH.

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
    1816
  • Date
    2016-02-05
  • 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 product has a problem with its secondary packaging.
  • Reason
    Defect in the packaging seal, which can potentially lead to non-sterility of the product.
  • Action
    Pick up and return to the manufacturer. Action code: RA 2015-172. Products that are still in stock, in the possession of distributors and / or hospitals must be returned to Stryker do Brasil.

Device

INSTRUMENTAL FOR STRINGS TS STRYKER TRAUMA, Wire Guide, register 80005430088, risk class I, lots ...

Manufacturer

Stryker do Brasil Ltda.; Stryker Trauma GmbH
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA