Events

Safety Alert for SYSTEM 6 - STRYKER ENGINES FOR ORTHOPEDICS - Registro ANVISA: 80005430141. Models: 6205-000-000 / 6208-000-000 and 6207-000-000. Serial No. of Products Affected: 0819004943; 0819306143; 0821740623.

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
    968
  • Date
    2009-07-20
  • 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 do Brasil outsources the distribution and technical assistance of this equipment to the company: BIOCAM Rua Dr. Alves do Banho, 890 Campinas - SP CEP 13030-580 Tel. 19 - 3272-3274 e-mail: biocam@biocam.com.br
  • Reason
    The equipment can continue to function even when the trigger is not depressed, potentially causing unintentional damage to soft tissue or bone.
  • Action
    The actions recommended to the users of the product are as follows: (1) Assemble the battery, connections and drills outside the surgical field; (2) Test the trigger system before the actual intervention. The company that owns the product registration has already ordered the kits for trigger repair, and must obey the attached action schedule. There was customer visitation (see distribution list) with promotion of guidelines and labeling on handpieces.

Device

SYSTEM 6 - STRYKER ENGINES FOR ORTHOPEDICS - Registro ANVISA: 80005430141. Models: 6205-000-000 /...

Manufacturer

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