Events

Safety Alert for SERFAS ENERGY NO SUCTION. Registro Anvisa n ° 80005430132. Product model: CODE 0279350101 - PONTEIRA SERFAS ENERGY 3,5MM 90 DEGREES. Affected lots: 13128AE2 to 14337AE2.

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 Endoscopy.

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
    1647
  • Date
    2015-07-28
  • 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
    Check your stock and segregate the products at risk as soon as possible, avoiding their use. Send Stryker the CUSTOMER RESPONSE form provided by the company.
  • Reason
    There is a potential risk of the probes related to the above mentioned batches rupturing and releasing fragments into the joint space, and an eventual need for immediate surgical intervention to remove the fragments may arise. in addition, there is a potential risk of the fragments remaining within the joint space, which may result in a compromise of function.
  • Action
    Product pickup.

Device

SERFAS ENERGY NO SUCTION. Registro Anvisa n ° 80005430132. Product model: CODE 0279350101 - PONTE...

Manufacturer

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