Retiro De Equipo (Recall) de SPEEDBRIDGE IMPLANT SYSTEM WITH BIOCOMPOSITE SWIVELOCK SP (SHOULDER)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ARTHREX INC.

¿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
    Recall
  • ID del evento
    77072
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-06
  • País del evento
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The self-punching eyelet contained within the arthrex swivelock sp suture anchor has the potential to break on insertion in hard cortical bone. there is no impact to the patient if the device has been implanted successfully.

Device

  • Modelo / Serial
    Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10081420); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10081420); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10076852); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10076852); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10076753); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10076753); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10084027); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10084027); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10074288); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10074288); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10074291); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10074291); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10075965); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10075965); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10077252); Model Catalog: AR-2600SBS-7 (Lot serial: batch# 10077252); Model Catalog: AR-2600SBS-5 (Lot serial: batch# 10070003); Model Catalog: AR-26
  • Descripción del producto
    SPEEDBRIDGE IMPLANT SYSTEM With BIOCOMPOSITE SWIVELOCK SP (SHOULDER);PEEK SWIVELOCK SELF-PUNCHING;BIO-COMPOSITE SWIVELOCK SELF-PUNCHING;BIO-SWIVELOCK SELF-PUNCHING
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    NAPLES
  • Empresa matriz del fabricante (2017)
  • Source
    HC