Events

Retiro De Equipo (Recall) de Device Recall OPT Croutons synthetic bone substitute

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 Acumed LLC.

¿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
    75904
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1019-2017
  • Fecha de inicio del evento
    2016-12-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151650
  • 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
    Opt croutons, part number 65-0210-s, is recalled due to the result of inadequate documentation of the sterilization dose used in production. product sterilized at the site did not receive the minimum dose required per the new performance qualification.
  • Acción
    Acumed sent the Urgent Recall Notice letter, dated December 1, 2016, to US customers on December 5, 2016. Customers are advised to follow the instructions provided by Acumed: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1. Perform a physical count of your inventory. 2. Remove the affected OPT Croutons, such that the croutons are out of service. 3. Record this data on the survey found following this recall letter. 4. Fill out the survey and return it via email to RecaiiNotification@acumed.net. 5. For any product that needs to be returned: Domestic Customers: please contact Acumed Agent Inventory via email at Agentlnventory@acumed.net or contact your agent directly to be assigned a Return Material Authorization (RMA) number and applicable shipping information. International Customers: please contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (877) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada) to be assigned a Return Material Authorization (RMA) number and applicable shipping information. 6. Once completed, please return the OPT Croutons that have been removed to Acumed using the Return Label provided by Acumed and included in your replacement shipment. Please contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (877) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada) with any questions regarding this notification.

Device

Device Recall OPT Croutons synthetic bone substitute
  • Modelo / Serial
    lot 549/12.001. Part number 65-0210-S.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
  • Descripción del producto
    OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Dirección del fabricante
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Empresa matriz del fabricante (2017)
    Acumed Llc
  • Source
    USFDA