Events

Alerte De Sécurité sur Titanium Bone Anchor Drivers: (1) With Integrated Nylon Sutures, (2) With Integrated Polypropylene Sutures; Fixers for AxyaLoop 5mm Titanium Bone Screws from the following sets of Shoulder Rotation Tendon Correction Procedures: (3) Arthroscopic, (4) Mini-Open. We. Catalog: (1) 1227; (2) 1221; (3) 1502-3, 1506-3; (4) 1501-3; Lots Nos .: (1) 201990, 201991; (2) 201827, 202049; (3) 202052, 202067, 202138, 202193; (4) 202051, 202066, 202183, 202192

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 Axya Medical 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
    688
  • Date
    2003-03-07
  • 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 rods of the above mentioned fasteners can break and do not fit with the fastener head (anchors). the manufacturer initiated a correction / recall by letter dated october 24, 2002.
  • Action
    Make sure you received the letter from Axya Medical on October 24, 2002. Identify and isolate any affected product in your inventory. For further information, please contact your local Axya representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Titanium Bone Anchor Drivers: (1) With Integrated Nylon Sutures, (2) With Integrated Polypropylen...

Manufacturer

Axya Medical Inc
  • Source
    ANVSANVISA