Device Recall Zimmer

  • Modèle / numéro de série
    Lot No: 60646894.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Inc., 345 E. Main St., Warsaw IN 46580-2304
  • Source
    USFDA

263 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Lots P050120 and P041466.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of California, Minnesota, Ohio, Pennsylvania, and Tennessee, and countries of Denmark, Germany, Iran, Italy, Russia, Singapore, Spain, Switzerland, and United Kingdom.
  • Description du dispositif
    Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. || Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 08701500, 60244766, 60254447, 60277967, 60289960, 60293969, 60313973, 60321519, 60331048, 60353723, 60360727, 60380526, 60406615, 60407562, 60422090, 60423663, 60454975, 60517608, 60685054, 60812396 and 60813212.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01. || The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
  • Manufacturer
  • Modèle / numéro de série
    Lots 60969810 and 60969811.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
  • Description du dispositif
    Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-14. || Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.
  • Manufacturer
  • Modèle / numéro de série
    Lots 61007188, 60987590, 60969807, 60976981 and 60976982.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
  • Description du dispositif
    Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-12. || Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.
  • Manufacturer
  • 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
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