Device Recall Tritium Sternal Plate System

  • Modèle / numéro de série
    Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of TX and FL
  • Description du dispositif
    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. || The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • Société-mère du fabricant (2017)
  • Source
    USFDA