Device Recall Zimmer NaturalKnee II System Modular Cemented Tibial Baseplate

Fabricant

  • Adresse du fabricant
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Lot 60830979.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.
  • Description du dispositif
    Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. || The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. || These are single use implantable devices sold sterile.
  • Manufacturer