Events

Alerte De Sécurité sur Model M / DN Intramedullary Humeral Fixation Plates. Catalog No. 00-2254-255-10; Lot # 20855000

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
    393
  • Date
    2002-02-15
  • 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 angled proximal drilling of some humerus plates above may be incorrectly oriented, making it impossible for the surgeon to guide the insertion of the screw into the target hole. the manufacturer initiated a correction by letter dated 30 october 2001.
  • Action
    Verify that you received the letter dated October 30, 2001; operating room questionnaire; prepaid card; addressed envelope; Zimmer distribution history report. Identify and isolate any affected product in your inventory. Contact your local Zimmer representative, who will return the affected product to the Zimmer service department. With the return of the product, you will receive the free replacement and total credit. Fill out the operating room questionnaire, and mail it to Connie Morgan, Zimmer, via prepaid mail, or via fax at (1574) 372-4265. For more information, please contact your local Zimmer representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

Model M / DN Intramedullary Humeral Fixation Plates. Catalog No. 00-2254-255-10; Lot # 20855000
  • Modèle / numéro de série
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • Source
    ANVSANVISA