Devices

Device Recall Serrated Soft Tissue Shields

  • Modèle / numéro de série
    Part numbers X079-0096 and X079-0097 with Lot #12320
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of FL and MO.
  • Description du dispositif
    Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
  • Manufacturer
    X Spine Systems Inc
  • 1 Event

Fabricant

X Spine Systems Inc
  • Adresse du fabricant
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Société-mère du fabricant (2017)
    X-Spine Systems, Inc
  • Source
    USFDA