Device Recall Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter

  • Modèle / numéro de série
    Model GP200. The four inserters were labeled with GP 200, Lot #1086.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including Florida and Texas.
  • Description du dispositif
    Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. || The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Genesys Orthopedic Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • Source
    USFDA