Events

Retiro De Equipo (Recall) de Device Recall PDS II (polydioxanone) Suture

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 Ethicon, 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
    51049
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1313-2009
  • Fecha de inicio del evento
    2009-02-02
  • Fecha de publicación del evento
    2009-05-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78288
  • 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
    Absorbable Polyglycolic Synthetic Suture - Product Code GAM
  • Causa
    Sterility issue: the firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.
  • Acción
    Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative. 5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.

Device

Device Recall PDS II (polydioxanone) Suture
  • Modelo / Serial
    Lot # Expiration Date APM091 2013-07-31 12:00AM APM861 2013-07-31 12:00AM APZ105 2013-07-31 12:00AM AMK590 2013-07-31 12:00AM APZ721 2013-07-31 12:00AM APZ098 2013-07-31 12:00AM APZ283 2013-07-31 12:00AM APM692 2013-07-31 12:00AM APM753 2013-07-31 12:00AM AP6005 2013-07-31 12:00AM APM748 2013-07-31 12:00AM APZ367 2013-07-31 12:00AM APM298 2013-07-31 12:00AM APZ245 2013-07-31 12:00AM AP6053 APZ644 2013-07-31 12:00AM APM524 2013-07-31 12:00AM APZ908 2013-07-31 12:00AM AP6061 2013-07-31 12:00AM APM635 2013-07-31 12:00AM APZ126 2013-07-31 12:00AM APZ298 2013-07-31 12:00AM APZ153 2013-07-31 12:00AM APZ381 2013-07-31 12:00AM AP2315 2013-07-31 12:00AM AP2333 2013-07-31 12:00AM AP2331 2013-07-31 12:00AM AP2332 2013-07-31 12:00AM AP2241 2013-07-31 12:00AM AP2355 2013-07-31 12:00AM APM221 2013-07-31 12:00AM APM844 2013-07-31 12:00AM
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.
  • Descripción del producto
    PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ. || Sutures are intended for general soft tissue approximation and/or ligation.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Dirección del fabricante
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA