Events

Alerte De Sécurité sur Stryker Femural Head. Registro Anvisa n ° 80005430072. Affected Codes and lots: See Product manufacturer's Alert Message, available at: http://portal.anvisa.gov.br/wps/wcm/connect/74cdfe004a8e435f8a73bb486c3ae08b/Carta+Cliente+RA+2014 -170.pdf? MOD = AJPERES

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par STRYKER DO BRASIL LTDA.; STRYKER ORTHOPAEDICS MAHWAH/HOWMEDICA OSTEONICS CORP..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1722
  • Date
    2015-11-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Failure detected on the product may cause improper functionality, excessive or insufficient strain on soft tissue, as well as lead to metal debris from metal wear and / or corrosion of the material. Such problems can cause surgical complications, loss of mobility, reduced range of motion, joint instability, inflammatory response, pain and adverse reactions associated with the implant. A difficulty in inserting the femoral head into the shaft may also cause a surgical delay of approximately 15 minutes.
  • Cause
    Risk of femoral heads not being properly inserted into the stem neck, or causing an inadequate locking force between the femoral head and the stem neck.
  • Action
    Product pickup by the record holder. Products at risk should not be used. Check your inventory and segregate the products at risk as soon as possible, identifying them to avoid inadvertent use.

Device

Stryker Femural Head. Registro Anvisa n ° 80005430072. Affected Codes and lots: See Product manuf...

Manufacturer

STRYKER DO BRASIL LTDA.; STRYKER ORTHOPAEDICS MAHWAH/HOWMEDICA OSTEONICS CORP.
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    ANVSANVISA