Retiro De Equipo (Recall) de Device Recall Origen DBM with Bioactive Glass

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 Nanotherapeutics, 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
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    On 03/10/2011 nanotherapeutics inc, alachua, fl initiated a recall of their origen dbm with bioactive glass catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). the same product is also distributed as nanofuse dbm catalog # nan109-02 (2cc) nan109-05 (5cc) and nan109-10(10cc). the products were manufactured without an approved 510k. direct accounts were notified of the recall on 04/08/2011.
  • Acción
    Nanotherapeutics sent an Urgent: Medical Device Recall letter dated April 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove any unimplanted/unsold product shipped to them. Customers were asked to notify their customers and instruct them to make notification until the end user (hospital/physician) is reached. Recall Instructions: Immediately examine inventory and quarantine product subject to recall. Return all quarantined product subject to recall to: Nanotherapeutics, Inc. Attn: Receiving Department 13859 Progress Blvd, Suite 300 Alachua, Florida 32615 For questions call 386-462-9663


  • Modelo / Serial
    Catalog # 22-2002 Lot #: 070281P, 070591P, 073221P, 073434P, 073504P, 073577PA, 073761PA, 073761PB, 074349P, 075075PA, 075128P, 075245PA, 075255P, 075259P, 077870PA, 078093PB, 078268PB.   Catalog # 22-2005 Lot #: 067559PA, 067559PB, 0700869, 070281P, 070546PA, 070546PB, 070552P, 070591P, 070743P, 070884PA, 070884PB, 073221P, 073222P, 073346PB, 073434P, 073496P, 073504P, 074032P, 075075PB, 075259P, 075481P, 075637PA, 075637PB, 075660P, 077642PA, 077870PB, 078048P, 078268PB, 078309PA, 079002PA.   Catalog # 22-2010 Lot #: 060095P, 067484P, 070203P, 070281P, 070512P, 070521P, 070603PA, 070607P, 070629P, 070703P, 070704P, 070755P, 070831P, 070916P, 071043PB, 071045PA, 071053PA, 071053PB, 073221P, 073319PB, 073346PA, 073346PB, 073411PB, 073434P, 073494PA, 073494PB, 073502P, 073590P, 073695P, 073751P, 073828P, 073879P, 075050PA, 075058P, 075167PB, 075230PA, 075230PB, 075245PB, 075338PA, 075338PB, 075492PA, 075629P, 077390P, 077715PA, 077715PB, 077863PA, 078093PA, 078268PA, 078268PB, 078344PB.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
  • Descripción del producto
    Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" || Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical, Inc by: Nanotherapeutics, Inc. 13859 Progress Blvd. suite 300 Alachua, FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney, TX 75069***Rx Only***ONE EACH***" || Origen DBM with Bioactive Glass Catalog #: || 22-2002 (2cc size) || 22-2005 (5cc size) || 22-2010 (10cc size) || "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." || Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
  • Manufacturer


  • Dirección del fabricante
    Nanotherapeutics, Inc, 13859 Progress Blvd Ste 300, Alachua FL 32615-9403
  • Empresa matriz del fabricante (2017)
  • Source