Events

Retiro De Equipo (Recall) de Device Recall NuOss XC Sinus

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 Collagen Matrix 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
    73206
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1097-2016
  • Fecha de inicio del evento
    2013-05-13
  • Fecha de publicación del evento
    2016-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143566
  • 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
    Bone grafting material, animal source - Product Code NPM
  • Causa
    During the 36 month real time shelf life testing of nuoss xc sinus (bmcu-umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.
  • Acción
    The firm, Collagen Matrix Inc., sent an email dated May 14, 2013 to its sole customer. The email described the product, problem and actions to be taken. The customer was instructed to return all product with expiration dates 12/2014 or earlier under Returned Goods, the firm will replace these products with new inventory; and return to Collagen Matrix, Inc., 15 Thornton Road, Oakland, NJ 07436 or quarantine products with expiration date 1/2016 until further notice. If you have any questions,call 201-405-1477 x 304 or email: www.collagenmatrix.com.

Device

Device Recall NuOss XC Sinus
  • Modelo / Serial
    Lot BMCXU11P1. BMCXU11H3  Lot BMCXU11P1, BMCXU12P1
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to state of: MA.
  • Descripción del producto
    NuOss XC Sinus || Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) || Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) || Manufacturer:- Collagen Matrix, || Distributor:- ACE Surgical Supply Co, Inc, || Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
  • Manufacturer
    Collagen Matrix Inc

Manufacturer

Collagen Matrix Inc
  • Dirección del fabricante
    Collagen Matrix Inc, 509 Commerce St, Franklin Lakes NJ 07417-1374
  • Empresa matriz del fabricante (2017)
    Collagen Matrix Inc.
  • Source
    USFDA