Events

Safety Alert for KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G, HPCB7B, HPDBGY, HPDBBL.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1266
  • Date
    2013-04-22
  • 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
    If the devices have been transferred to other organizations, we ask that you provide the organization's name and contact information on the Field Correction Confirmation Form and forward a copy of this Field Security Notification to the organization to which the device was transferred. If you have further questions or concerns about the information contained in this Field Safety Notice, please contact the representative.
  • Reason
    The company informs that during the injection of cement, water in the hydraulic pump leaks into the pump body after passing through the piston, resulting in loss of pressure and inability to continue to inject cement. this may result in delayed surgery to prepare another kit or to close the procedure earlier than intended, which could result in the patient having to undergo additional anesthesia as a result of another surgical procedure.
  • Action
    The company requests that the above-described combinations of product code and batch number be removed from service and contact your DePuy Synthes Spine * representative to arrange product return, credit and / or replacement. They further request that this information be distributed to relevant personnel in the services, including surgeons who may have received the product, the subject of this notification. See Letter to the Client at: http: //portal.anvisa.gov.br/wps/wcm/connect/4d1748804ff803369991ff6d6e8afaaa/KIT_CONFIDENCE_PLUS_FORMULARIO_DE_CONFIRMACAO_2_.pdf? MOD = AJPERES

Device

KIT CONFIDENCE PLUS - Kit Confidence Plus (11 cc) - Record no. 80145901323, lots: HPBB2B, HPBB2G,...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda