Device Recall SCORPIOFLEX CR TIBIAL TRIAL

  • Model / Serial
    T72-5-0308A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 8 MM T72-5-0310A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 10 MM T72-5-0312A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 12 MM T72-5-0315A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 15 MM T72-5-0318A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 18 MM T72-5-0321A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 21 MM T72-5-0324A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 24 MM T72-5-0508A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 8 MM T72-5-0510A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 10 MM T72-5-0512A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 12 MM T72-5-0515A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 15 MM T72-5-0518A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 18 MM T72-5-0521A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 21 MM T72-5-0524A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 24 MM T72-5-0708A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 8 MM T72-5-0710A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 10 MM T72-5-0712A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 12 MM T72-5-0715A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 15 MM T72-5-0718A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 18 MM T72-5-0721A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 21 MM T72-5-0724A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 24 MM T72-5-0908A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 8 MM T72-5-0910A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 10 MM T72-5-0912A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 12 MM T72-5-0915A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 15 MM T72-5-0918A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 18 MM T72-5-0921A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 21 MM T72-5-0924A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 24 MM T72-5-1108A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 8 MM T72-5-1110A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 10 MM T72-5-1112A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 12 MM T72-5-1115 SCORPIO SUPERFLEX PS TIB.TRIAL, SIZE 11, 15 MM T72-5-1115A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 15 MM T72-5-1118A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 18 MM T72-5-1121A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 21 MM T72-5-1124A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 24 MM All lots.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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-FLEX 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