Events

Alerte De Sécurité sur Femoral Ceramic Head, Alumina, with anchorages (Chrome-Cobalt Taper) 12/14: (1) 26 mm Diameter / + 0 mm Collar Length, (2) 26 mm Diameter / +3.0 mm Length Colo, (3) 26 mm Diameter / +3.5 mm Collar Length

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 Zimmer Inc.

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
    696
  • Date
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The data resulting from the femoral head static compression test quoted above indicated that there was no compliance with the specifications required for the critical reference levels [see "fda guidance document for the preparation of premarket notifications for ceramic ball hip systems"]. the manufacturer initiated a recall by letter dated january 6, 2003.
  • Action
    Verify that you received the Zimmer notification letter and questionnaire on January 6, 2003. Identify and isolate any affected product in your inventory, protect the product from future use, and contact your local Zimmer representative who will return the product to Zimmer. ANVISA recommends that you locate all the units mentioned above that have been deployed in your institution and by whom. Inform the surgeons who proceed the implants that the product has been subject to a recall. The surgeon must decide whether medical intervention in the patient who received the implant is necessary. Total credit will be given for the returned product. Return the notification questionnaire by mail using the pre-addressed or faxed envelope to Connie Morgan at 0021-1 (574) 372-4265. For further information, please contact your local Zimmer representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Femoral Ceramic Head, Alumina, with anchorages (Chrome-Cobalt Taper) 12/14: (1) 26 mm Diameter / ...
  • Modèle / numéro de série
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • Source
    ANVSANVISA