Retiro De Equipo (Recall) de Device Recall CollaGuide Collagen Dental Membrane

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 Kensey Nash Corp.

¿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 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Barrier, animal source, intraoral - Product Code NPL
  • Causa
    Recall has been initiated due to concerns regarding the sterility of the product. the firm initiated the recall because of use of inadequately sterilized product might result in patient infection,.
  • Acción
    Reimser, Inc. sent an "URGENT PRODUCT RECALL-COLLAGUIDE COLLAGEN DENTAL MEMBRANE" letter dated March 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to cease use, secure and quarantine affect product. Additionally, a Recall Acknowledgement Form was attached for customers to complete and return to the firm via fax to 1-800-505-4982. Contact the firm at 484-713-2197 for questions regarding this recall.


  • Modelo / Serial
    20mm X 30mm Part number 20650-02 Lot # 91025 Expiration date 07/31/12 Lot # 92339 Expiration date 10/31/12 Lot # 94765 Expiration date 03/31/13 Lot # 95276 Expiration date 05/31/13 Lot # 95911 Expiration date 05/31/13 Lot # 97040 Expiration date 08/31/13 Lot # 98319 Expiration date 11/30/13 Lot # 84505 Expired Lot # 85271 Expired Lot # 89495 Expired Lot # 89542 Expired
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. || Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only || 20mm X 30mm REF 20650-02 6280-02 Rev.AE || Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. || CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
  • Manufacturer


  • Dirección del fabricante
    Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341
  • Empresa matriz del fabricante (2017)
  • Source