Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 62185968 62273370 62339644 62162469 62279774 62279774N 62221051 62279775 62279775N
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 28 consists of all product under product code: JDI and same usage: || Item no: || 32902605000 FEMORAL HD 28MM MEDIUM || 32902604000 FEMORAL HD 28MM SHORT || 32902604035 FEMORAL HD 28MM SHT+ 3.5M || For use in total or hemi 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
    All lots.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.
  • Description du dispositif
    Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-03 and 00-6428-032-03. || The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
  • Manufacturer
  • 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
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