Device Recall Synthes Craniomaxillofacial (CMF) Distraction System

  • Modelo / Serial
    Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including PA, CT, DE, and NY.
  • Descripción del producto
    Synthes CMF Distraction System || The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
  • Manufacturer
  • 1 Event

Fabricante

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