Events

Alerte De Sécurité sur Easy-to-install dental prosthesis abument kits. Catalogs nos. (1) 61641 through 61644, (2) 62645 to 61648, (3) 61649 through 61652, (4) 61656, (5) 61657, (6) 61658; Lots nºs. (1) 320130, 320150, 320151, 320161 to 320164, 320403 to 320409, 320482, 320926, 321748, 321749; (2) 320172, 320174, 320179 to 320181, 320927 to 320931, 321750, 321752, 322079 to 322081, 322664, 322668, 322669, 322672, 333082; (3) 320182 to 320185, 321325, 321440 to 321442, 322083, 322084; (4) 321679, 326218; (5) 321680, 324398, 326342; (6) 321681; 3,595 units distributed in USA and internationally

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 Nobel Biocare USA 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
    277
  • Date
    2002-01-25
  • 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 above mentioned parts were sterilized and labeled "sterile" during the beginning of the manufacturing process. however, during the rework process, it is possible that some of the batches identified above have not been resterilized. the manufacturer initiated a letter correction dated july 13, 2001, to warn customers that some products from suspect lots may have been transported without resterilization. to date, 804 of the 3,595 articles have already been returned to the manufacturer.
  • Action
    Make sure you have received the Nobel Biocare letter of July 13, 2001. Identify and isolate any affected product in your inventory. For more information, contact your local Nobel Biocare representative or directly at 1 (714) 282-4800 ext. 5073 in the USA.

Device

Easy-to-install dental prosthesis abument kits. Catalogs nos. (1) 61641 through 61644, (2) 62645 ...

Manufacturer

Nobel Biocare USA Inc
  • Source
    ANVSANVISA