Device Recall Universal Spinal System Lamina Hooks

  • Modèle / numéro de série
    Catalog number 498.321, lot/serial #6876785
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
  • Description du dispositif
    Universal Spinal System Lamina Hooks || Synthes Medium TI Lamina Hook - Right || 498.320 || Non sterile || LOT 6876785 || Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Société-mère du fabricant (2017)
  • Source
    USFDA