Device Recall Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert;

  • Modèle / numéro de série
    Catalog No. 626-00-XXY (XXY= 36C, 38D, 42E, 46F, 48G, 52H, 54I, 58J) All lots K103233
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France || The MDM Liner and X3 Acetabular Inserts is a sterile single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica osteonics 22.2 mm and 28 mm diameter femoral heads.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
  • Source
    USFDA