Events

Retiro De Equipo (Recall) de Device Recall UltOS 3.5mm locking screw (12mm to 50mm)

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 Ortho Solutions 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
    71899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0026-2016
  • Fecha de inicio del evento
    2015-07-14
  • Fecha de publicación del evento
    2015-10-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139303
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Ortho solutions inc is initiating a recall on behalf of ultos 3.5mm locking screw. the locking thread feature of the screw was not manufactured to specification. as a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. in the event of this occurring the non functioning screw would need to be replaced with an alternativ.
  • Acción
    The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho Solutions, Inc. via fax to: 201-335-0759 by 16 July 2015. If you should have any queries relating to this matter or require any additional information, contact General Manager at 201-906-6175.

Device

Device Recall UltOS 3.5mm locking screw (12mm to 50mm)
  • Modelo / Serial
    Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
  • Descripción del producto
    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile || Orthopaedic Bone Screw
  • Manufacturer
    Ortho Solutions Inc

Manufacturer

Ortho Solutions Inc
  • Dirección del fabricante
    Ortho Solutions Inc, 330 Franklin Tnpk, Mahwah NJ 07430
  • Empresa matriz del fabricante (2017)
    Ortho Solutions Inc.
  • Source
    USFDA