Events

Retiro De Equipo (Recall) de Device Recall USS Small Stature

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 Synthes USA HQ, 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
    65563
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1935-2013
  • Fecha de inicio del evento
    2013-06-05
  • Fecha de publicación del evento
    2013-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119580
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Causa
    Depuy synthes has issued a medical device correction notice for the 5.0mm stainless steel rods. this product was produced using a finishing process not identified as part of the manufacturing specification. no adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t.
  • Acción
    On June 5, 2013, De Puy Synthes notified by letter the direct acc acccounts which were identified to have received 5.0mm stainless steel rods and requested return of the product by calling 1-800-479-6329 to obtain a return authorization number. Completion of the verification section of the letter, including negative responses was also requested.

Device

Device Recall USS Small Stature
  • Modelo / Serial
    Part Numbers: 298.269 298.270 298.271 298.272 298.273 298.274 298.275 298.276 298.277 298.278  with lot numbers:  4729951; 4841209; 4923651; 4923652; 4987688; 4987750; 5350635; 2002330; 3000595 4729952; 4841210; 4923653; 4923654; 4987683; 4856248; 4987755; 5153848; 5153853; 1602596; 1880489 4729953; 4841211; 4923666; 4923667; 4987778; 4856275; 4987761; 5159826; 5157329; 3016224  4729954; 4841212; 4919162; 4923669; 4987779; 4856250; 4987766; 5153796; 3093619 4729956; 4923674; 4987825; 4987780; 5066363 4729958; 4923615; 4987826; 4987781; 5066364 4729959; 4841213; 4923655; 4936270; 4987684; 4987771; 5153849; 5153854 4729960; 4835367; 4923656; 4923657; 4984982; 4856246; 4987772; 5159827; 5157330  4729961; 4835368; 4923658; 4923659; 4987685; 4856249; 4987773; 1602617; 3080451 4729962; 4835378; 4919165; 4923660; 4987686; 4856252; 4987776; 5153851
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    5.0mm Unit Rod 270mm || 5.0mm Unit Rod 290mm || 5.0mm Unit Rod 310mm || 5.0mm Unit Rod 330mm || 5.0mm Unit Rod 350mm || 5.0mm Unit Rod 370mm || 5.0mm Unit Rod 390mm || 5.0mm Unit Rod 410mm || 5.0mm Unit Rod 430mm || 5.0mm Unit Rod 450mm || pedicle screw spinal system; || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • Dirección del fabricante
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA