Events

Safety Alert for STATIVE. Models under risk: 0682000976 and 0682000977. Anvisa Registry No. 80005430276.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by STRYKER DO BRASIL LTDA..

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
    1469
  • Date
    2014-12-01
  • 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
    STRYKER was aware of the possibility that the bolt and locking washer are not present on the SHAPE arm of the equipment in question. If the bolt and lock washer are not present on the SHAPE arm, the monitor may fall apart and fall, potentially resulting in severe injury or death.
  • Reason
    Locking screw and washer may not be present on the shape arm.
  • Action
    Field Correction - Verification by the Stryker service technician of the equipment locking bolt / washer.

Device

STATIVE. Models under risk: 0682000976 and 0682000977. Anvisa Registry No. 80005430276.

Manufacturer

STRYKER DO BRASIL LTDA.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA