Device Recall LEGION HK FEMORAL WEDGE

  • Modelo / Serial
    Batch Number14AAP6352A
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution to the states of: NY, IL, NJ, TX, CO, and to the countries of : Belgium, Great Britain, Australia, Germany, Netherlands, Norway.
  • Descripción del producto
    smith&nephew;, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE || The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA