Devices

Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM

  • Modèle / numéro de série
    Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : IL, MI, NY, CA, VA and NV.
  • Description du dispositif
    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
  • Manufacturer
    Orthosensor, Inc.
  • 1 Event

Fabricant

Orthosensor, Inc.
  • Adresse du fabricant
    Orthosensor, Inc., 1560 Sawgrass Corporate Pkwy, 4th Floor, Sunrise FL 33323-2858
  • Société-mère du fabricant (2017)
    OrthoSensor Inc.
  • Source
    USFDA