Device Recall SCORPIO CR TIBIAL TRIAL

  • Model / Serial
    T72-2-0308 SCORPIO CR TIBIAL TRIAL, SIZE 3, 8 MM T72-2-0310 SCORPIO CR TIBIAL TRIAL, SIZE 3, 10 MM T72-2-0312 SCORPIO CR TIBIAL TRIAL, SIZE 3, 12 MM T72-2-0315 SCORPIO CR TIBIAL TRIAL, SIZE 3, 15 MM T72-2-0318 SCORPIO CR TIBIAL TRIAL, SIZE 3, 18 MM T72-2-0321 SCORPIO CR TIBIAL TRIAL, SIZE 3, 21 MM T72-2-0324 SCORPIO CR TIBIAL TRIAL, SIZE 3, 24 MM T72-2-0508 SCORPIO CR TIBIAL TRIAL, SIZE 5, 8 MM T72-2-0510 SCORPIO CR TIBIAL TRIAL, SIZE 5, 10 MM T72-2-0512 SCORPIO CR TIBIAL TRIAL, SIZE 5, 12 MM T72-2-0515 SCORPIO CR TIBIAL TRIAL, SIZE 5, 15 MM T72-2-0518 SCORPIO CR TIBIAL TRIAL, SIZE 5, 18 MM T72-2-0521 SCORPIO CR TIBIAL TRIAL, SIZE 5, 21 MM T72-2-0524 SCORPIO CR TIBIAL TRIAL, SIZE 5, 24 MM T72-2-0708 SCORPIO CR TIBIAL TRIAL, SIZE 7, 8 MM T72-2-0710 SCORPIO CR TIBIAL TRIAL, SIZE 7, 10 MM T72-2-0712 SCORPIO CR TIBIAL TRIAL, SIZE 7, 12 MM T72-2-0715 SCORPIO CR TIBIAL TRIAL, SIZE 7, 15 MM T72-2-0718 SCORPIO CR TIBIAL TRIAL, SIZE 7, 18 MM T72-2-0721 SCORPIO CR TIBIAL TRIAL, SIZE 7, 21 MM T72-2-0724 SCORPIO CR TIBIAL TRIAL, SIZE 7, 24 MM T72-2-0908 SCORPIO CR TIBIAL TRIAL, SIZE 9, 8 MM T72-2-0910 SCORPIO CR TIBIAL TRIAL, SIZE 9, 10 MM T72-2-0912 SCORPIO CR TIBIAL TRIAL, SIZE 9, 12 MM T72-2-0915 SCORPIO CR TIBIAL TRIAL, SIZE 9, 15 MM T72-2-0918 SCORPIO CR TIBIAL TRIAL, SIZE 9, 18 MM T72-2-0921 SCORPIO CR TIBIAL TRIAL, SIZE 9, 21 MM T72-2-0924 SCORPIO CR TIBIAL TRIAL, SIZE 9, 24 MM T72-2-1108 SCORPIO CR TIBIAL TRIAL, SIZE 11, 8 MM T72-2-1110 SCORPIO CR TIBIAL TRIAL, SIZE 11, 10 MM T72-2-1112 SCORPIO CR TIBIAL TRIAL, SIZE 11, 12 MM T72-2-1115 SCORPIO CR TIBIAL TRIAL, SIZE 11, 15 MM T72-2-1118 SCORPIO CR TIBIAL TRIAL, SIZE 11, 18 MM T72-2-1121 SCORPIO CR TIBIAL TRIAL, SIZE 11, 21 MM T72-2-1124 SCORPIO CR TIBIAL TRIAL, SIZE 11, 24 MM All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.
  • Product Description
    SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
  • Source
    USFDA