Events

Retiro De Equipo (Recall) de SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Synthes USA.

¿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
    60051
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0460-2012
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104316
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    A recent shipment carrying norian srs was lost by the carrier. since the product was lost before final product release testing, synthes is unable to confirm that part number srs-005-fsp- lot number n001101 meets final product release requirements. the product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.
  • Acción
    All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident.

Device

SRS FAST SET PUTTY 3 CC BONE VOID FILLERSTERILE
  • Modelo / Serial
    Part Number SRS-005-FSP, Lot number N001101
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Synthes USA sent a "NOTICE: MISSING SHIPMENT-NORIAN SRS" letter dated September 29, 2011 to all accounts with a history of purchasing the product in the past two years. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory to verify they have not received the affected product. Call 1-800-620-7025 ext. 5450 for questions concerning this notice.
  • Descripción del producto
    SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. || Bone void filler.
  • Manufacturer
    Synthes USA

Manufacturer

Synthes USA
  • Dirección del fabricante
    Synthes USA, 1230 Wilson Dr, West Chester PA 19380-4231
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA