Devices

Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System

  • Modèle / numéro de série
    Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the states of :CA and TX.
  • Description du dispositif
    Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ || Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
  • Manufacturer
    ConforMIS, Inc.
  • 1 Event

Fabricant

ConforMIS, Inc.
  • Adresse du fabricant
    ConforMIS, Inc., 28 Crosby Dr, Bedford MA 01730-1402
  • Société-mère du fabricant (2017)
    Conformis Inc
  • Source
    USFDA