Events

Alerte De Sécurité sur INSTRUMENTAL NON-JOINT NON-ROLLER, Model RIA Locking Clamp - Single Size, Registration No. 80145901733. Code: 352.260S, Lot 2671884

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

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
    1737
  • 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
    The company reports that the leachate (liquefied constituents) of a non-biocompatible device can generate an adverse reaction to the tissue. This is an undesired and excessive inflammatory response to foreign material (chemical, biological or physical) within the body. Medical or surgical treatment is ideal and no permanent impairment is expected. The possibility of such damage is considered remote since the material used in the device has been submitted and approved in the package integrity test (integrity of the seal and integrity of the sterile barrier) and biocompatibility and is stable after sterilization by an expiration date of 2 years.
  • Cause
    The expiration date on the product label has been found to be incorrect. existing tests confirm an expiration date of 2 years from the date of manufacture. the affected products on the market were labeled with an expiration date of 10 years. biocompatibility tests support an expiration date of 2 years only.
  • Action
    The company is performing the product collection and guides to identify and separate the involved lot and return it to its representative. (Field Action Code: R2014085)

Device

INSTRUMENTAL NON-JOINT NON-ROLLER, Model RIA Locking Clamp - Single Size, Registration No. 801459...

Manufacturer

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