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

  • Modelo / Serial
    Catalog No. 626-00-XXY (XXY= 36C, 38D, 42E, 46F, 48G, 52H, 54I, 58J) All lots K103233
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA