Device Recall Endoskeleton Locking Bone Screw Assembly

  • Modèle / numéro de série
    Lot numbers: V03, V05, V06
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
  • Description du dispositif
    Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; || 5302-3516 / 03.5 x 16mm Locking Screws; || 502-3518 / 03.5 x 18mm Locking Screws; || 5302-3814 / 03.8 x 14mm Locking Screws; || 5302-3816 / 03.8 x 16 mm Locking Screws; || 5302-3818 / 03.8 x 18mm Locking Screws.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    TITAN SPINE, LLC, 6140 W Executive Dr, Suite A, Mequon WI 53092-4499
  • Société-mère du fabricant (2017)
  • Source
    USFDA