Device Recall Cervical Plate

  • Modèle / numéro de série
    Catalog Number 05-100-03-0042, Lot # 68122001.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to Florida only.
  • Description du dispositif
    Exactech Ambassador Cervical Plate System || The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Société-mère du fabricant (2017)
  • Source
    USFDA