Device Recall Synthes Craniomaxillofacial (CMF) Distraction System

  • Model / Serial
    Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution including PA, CT, DE, and NY.
  • Product Description
    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


  • Manufacturer Address
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
  • Source