Events

Alerte De Sécurité sur #Product: Shadowteck Lumbar Intervertebral Spacer. #Register # 80371250007.. #Models: PSHWPB001 - 7mm; PSHWPB002 - 8mm; PSHWPB003 - 9mm; PSHWPB004 - 10mm; and PSHWPB005 - 11mm. . # Model PSHWPB001 - Shadowteck Lumbar Intervertebral Spacer - 7mm Lots: PSHW121; PSHW181; PSHW203. # Model PSHWPB002 - Shadowteck Lumbar Intervertebral Spacer - 8mm. Lots: PSHW116; PSHW182; PSHW202. # Model PSHWPB003 - Shadowteck Lumbar Intervertebral Spacer - 9mm. Lots: PSHW117; PSHW185; PSHW201. # Model PSHWPB004 - Shadowteck Lumbar Intervertebral Spacer - 10mm. Lots: PSHW118; PSHW187; PSHW200. # Model PSHWPB005 - Shadowteck Lumbar Intervertebral Spacer - 11mm. Lots: PSHW119; PSHW188; PSHW199

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 Bioteck Ind.Com.Imp. e Exp. de Implantes Bio-Absorvíveis Ltda..

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
    1216
  • Date
    2012-11-29
  • 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
    According to the company's assessment, an error has occurred and it is not a question of forgery of the product. It emphasizes that there is no risk associated with the product and / or its validity. That is, there is no risk to the health of customers / patients associated with the use of the affected product. Such an event will not cause misfortune to the clients / patients since they have received product with the expiration date informed prior to the actual expiration date of the product. ANVISA and VISA RS are following the Field Action.
  • Cause
    Detected divergence in the date of manufacture format and validity of the shadowteck lumbar spacer in relation to the format defined in the product registration process; the divergence detected is the dates printed on the labels of products in year / month / day format, and in the product registration was defined by the format day / month / year. it was found that the label dates of the shadowteck lumbar intervertebral spacer (carton) and secondary (aluminized) carton labels were in disagreement with the dates of manufacture and validity stated on the blister, which were within the expiration date less than the defined term of two years from the date of manufacture.
  • Action
    Correction in date format on product labeling.

Device

#Product: Shadowteck Lumbar Intervertebral Spacer. #Register # 80371250007.. #Models: PSHWPB001 -...

Manufacturer

Bioteck Ind.Com.Imp. e Exp. de Implantes Bio-Absorvíveis Ltda.
  • Source
    ANVSANVISA