Retiro De Equipo (Recall) de Affinis Inverse inlay ceramys & Affinis Fracture ceramic heads (Total Shoulder System that is designed for treating shoulder conditions)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mathys Orthopaedics Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer, mathys ltd bettlach, received reports of disconnection of affinis inverse inlay ceramys and affinis fracture ceramic heads. subsequent investigations have identified that the inlay and individual implant components complied with the defined specifications.For affinis fracture ceramic heads:the disconnections may have resulted from inadequate primary fixation due to insufficient head-cone connection or by protruding bone residue, cement residue or soft tissue fragments inside the cone connection.For affinis inverse inlay ceramys: the disconnection incident was caused by insufficient fixation of the inlay on the cone due to lack of impaction. the affinis inverse inlay ceramys has not been supplied in australia.To minimise occurrences of disconnection, additional instructions and notes regarding ceramic inlay implantation and ceramic head implantation have been added to the surgical technique and the instructions for use (ifu).
  • Acción
    Mathys Ltd Bettlach is requesting the customers to replace all Surgical Techniques and Instructions for Use (IFUs) for Affinis Inverse and/or Affinis Fracture with the updated versions provided. The sponsor has directly contacted the surgeon to notify of the implications of inadequate fixation and to provide the updated instructions. Further information will be published on the TGA web site at This action has been closed-out on 14/07/2016.


  • Modelo / Serial
    Affinis Inverse inlay ceramys & Affinis Fracture ceramic heads (Total Shoulder System that is designed for treating shoulder conditions)Affinis Inverse inlay ceramysItem numbers: 62.34.0066, 62.34.0067, 62.34.0068, 62.34.0069, 62.34.0070 62.34.0071, 62.34.0072, 62.34.0073 & 62.34.0074 Affinis Fracture ceramic headsItem numbers: 60.25.0042, 60.25.0045 & 60.25.0048 All Batch numbersARTG number: 215501
  • Manufacturer