Events

Alerte De Sécurité sur #Product: Masterteck Peek LT1 Screw. #Registration: 80371250004.. #Models: PMASPK001 - 7x24mm, PMASPK002 - 7x30mm, PMASPK003 - 8x24mm, PMASPK004 - 8x30mm, PMASPK005 - 9x24mm, PMASPK006 - 9x30mm, PMASPK007 - 10x24mm, PMASPK008 - 10x30mm. . # PMASPK001-Masterteck Screw - 7x24mm - Batch PMAS190 ;. # PMASPK002-Masterteck Screw - 7x30mm - Batch PMAS196 ;. # PMASPK003-Masterteck Screw - 8x24mm - Batch PMAS195 ;. # PMASPK004-Screw Masterteck - 8x30mm - Lot PMAS194 ;. # PMASPK005-Masterteck Screw - 9x24mm - Batch PMAS193 ;. # PMASPK006-Masterteck Screw - 9x30mm - Batch PMAS192 ;. # PMASPK007-Masterteck Screw - 10x24mm - Batch PMAS189 ;. # PMASPK008-Screw Masterteck - 10x30mm - Lot PMAS191 ;. # PMASPK009-Masterteck Screw - 11x24mm - Batch PMAS197 ;. # PMASPK010-Masterteck Screw - 11x30mm - Pack PMAS198.

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
    1217
  • 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, there is no risk to the health of customers / patients associated with the use of the affected product. ANVISA and VISA RS are following the Field Action.
  • Cause
    Discrepancy was detected in the date of manufacture and the validity of the masterteck peek lt1 screw in relation to the format defined in the product registration process. the divergence detected is the dates printed on the labels of the products in year / month / day format, and in the product registration was defined by the format day / month / year. according to the evaluation of the company has occurred error, it is not about falsification of the product and there is no risk associated with the product and / or its validity.
  • Action
    Date format correction on product labeling.

Device

#Product: Masterteck Peek LT1 Screw. #Registration: 80371250004.. #Models: PMASPK001 - 7x24mm, PM...

Manufacturer

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