Events

Retiro De Equipo (Recall) de DePuy Spine

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 DePuy 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
    75454
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0628-2017
  • Fecha de inicio del evento
    2016-10-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150411
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Causa
    Skyline variable ti screws may have contained skyline constrained ti screws within the packaging.
  • Acción
    The firm, DePuy Synthes Spine, sent an "URGENT! VOLUNTARY PRODUCT CORRECTION NOTIFICATION" letter dated 10/12/2016 to its Customers. Sales consultants supporting these customers received an email notification with required reply forms. The letter described the product, problem and actions to be taken. A DePuy Synthes Spine Sales consultant has been notified and will be reviewing inventory to ensure correct screw placement within your set. The customers were instructed to review, complete, sign and return the attached business reply form to DePuy Synthes Spine via email to: DPYUS-SpineFieldActions@its.jnj.com within 5 business days of receipt of this notification; forward the notice to anyone in your facility that needs to be informed; if devices have been forwarded to another facility, contact that facility and provide them with notice, and keep a copy of the notice. Questions about this recall, please contact Recall Coordinator, DePuy Synthes Spine (via telephone: 508.828.3647 or via email: DPYUS- SpineFieldActions@its.jnj.com).

Device

DePuy Spine
  • Modelo / Serial
    Lot Codes: AFFBMZ AFN6D5 AMMDVJ
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.
  • Descripción del producto
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm || Item Code: 186854018 || The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Dirección del fabricante
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA