Events

Retiro De Equipo (Recall) de Device Recall Altius MINI OCT Posterior Spinal Fixation System

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 Zimmer Biomet Spine, 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
    76610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1691-2017
  • Fecha de inicio del evento
    2017-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153660
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Causa
    Zimmer biomet is recalling the altius m-ini oct posterior spinal fixation system because the driver is unable to mate with the screw head tulip.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall letter on March 20, 2017, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignee's Responsibilities 1. Review this notification and ensure affected team members are aware of the contents. 2. Prior to sending Altius Kits to central processing, perform a functional check of the driver withall screws in the kit to ensure they mate. If the drivers do not mate, please return in accordance with Step 3b. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form  Phase I. b. If the driver is unable to mate with the screws in the set, immediately sterilize and return the affected nonconforming product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form  Phase I and Attachment 2  Certificate of Sterilization to Zimmer Biomet. i. For each return, send a copy of Attachment 1 to jeremy.hansmann@zimmerbiomet.com ii. Include a hardcopy of Attachment 1 with your shipment for immediate processing. iii. Include a copy of Attachment 2  Certificate of Sterilization with returned instruments. iv. Mark the outside of the returns box(es) clearly with RECALL. 4. Distributors will notify their accounts to which the product was further distributed and to locate and return products from these accounts. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that have the affected product. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Retain a copy of your field action acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 6. If

Device

Device Recall Altius MINI OCT Posterior Spinal Fixation System
  • Modelo / Serial
    505951,M16562R01,505951,510710,510981,514814,533566,536398,543663,546565,546566,549528,565465,565464,567525,
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to the Netherlands
  • Descripción del producto
    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 || The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
  • Manufacturer
    Zimmer Biomet Spine, Inc

Manufacturer

Zimmer Biomet Spine, Inc
  • Dirección del fabricante
    Zimmer Biomet Spine, Inc, 310 Interlocken Pkwy, Suite 120, Broomfield CO 80021-3479
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA