Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 61674472 61906696 62016799 62332483 61674473 61902194 61906697 62326386 61674476 61953546 62161131 62172656 62326385 61953547 62011539 62017894 62130757 61886072 61953548 62017895 62172659 61886073 61948763 61953551 62172661 61874793 61948764 61996232 62017897 62172663 61874794 61953554 62286122
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 33 consists of all product under product code: JDI and same usage: || Item no: || 662406515 HGP II ACETABULAR CUP BON || 662406520 HGP II ACETABULAR CUP BON || 662406525 HGP II ACETABULAR CUP BON || 662406530 HGP II ACETABULAR CUP BON || 662406535 HGP II ACETABULAR CUP BON || 662406540 HGP II ACETABULAR CUP BON || 662406550 HGP II ACETABULAR CUP BON || 662406560 HGP II ACETABULAR CUP BON || For use in total hip arthroplasty
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

263 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • 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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