Events

Alerte De Sécurité sur Intervertebral Spacer Cervical Shadowteck Technical Name: Disc Intervertebral Spacing Device ANVISA Registration Number: 80371250016 Hazard Class: III Affected Model: PSHCPB003 - Cervical Intervertebral Spacer Shadowteck 6.0 mm Serial Numbers Affected: 01 (one) lot denominated PSHC746.

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 Indústria e Comércio, Importação e Exportação 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
    2307
  • Date
    2017-05-31
  • 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
    Return the product for rework by correcting traceability labels. Attach the statement about the divergence in the lot, along with the records of product traceability in the hospital and for the patient.
  • Cause
    We inform you that master hospitalar identified a divergence in the batch constant code on the set of 05 (five) traceability labels (labels: from ro0011 to ro0015) of the product in question and informed biotek via email on 05/25 / 2017. on the traceability labels, instead of the correct batch, pshc746, as written to the internal product, product history record, and other labels, the code for another batch kdve15r was mistakenly entered.
  • Action
    Field Action Code RNC557 and RRM05 triggered under the responsibility of Bioteck Indústria e Comércio, Importacao e Exportação de Implantes Bio-Absorvíveis Ltda. Company will collect.

Device

Intervertebral Spacer Cervical Shadowteck Technical Name: Disc Intervertebral Spacing Device ANVI...

Manufacturer

Bioteck Indústria e Comércio, Importação e Exportação de Implantes Bio-Absorvíveis Ltda.
  • Source
    ANVSANVISA