Device Recall Zimmer

  • Modelo / Serial
    Item numbers: 7210-22-000; 7210-22-350; 7210-22-800; 7210-26-000; 7210-26-035; 7210-26-350; 7210-26-800; 7210-28-000; 7210-28-004; 7210-28-400; 7210-28-800; 7210-32-000; 7210-32-004; 7210-32-400; 7210-32-800.  Lot #'s:  61487412, 61516918, 61525215, 61533617, 61582735, 61417397, 61487413, 61417398, 61393996, 61393997, 61417401, 61417402, 61487414, 61487415, 61487416, 61487417, 61487418, 61487420, 61487422, 61487423, 61495211, 61495212, 61500247, 61516884, 61516885, 61516886, 61516888, 61525212, 61525213, 61533606, 61533607, 61533608, 61538022, 61538024, 61538026, 61554502, 61565073, 61565079, 61565081, 61565082, 61582736, 61417403, 61487424, 61487425, 61487426, 61495218, 61516903, 61516904, 61525214, 61533612, 61565084, 61565085, 61577701, 61582737, 61417399, 61487427, 61487428, 61487429, 61495210, 61516881, 61516882, 61533605, 61538021, 61543660, 61565071, 61565072, 61487443, 61565088, 61487447, 61487450, 61500252, 61525210, 61533616, 61565091, 61565104, 61582738, 61487453, 61500245, 61525209, 61565102, 61394048, 61487455, 61500250, 61538042, 61577704, 61487456, 61565101, 61382197, 61394027, 61394029, 61417404, 61417405, 61487571, 61487572, 61487573, 61487574, 61487575, 61487576, 61487577, 61495217, 61516893, 61516894, 61516896, 61516897, 61516898, 61525224, 61525225, 61525226, 61533610, 61538041, 61543661, 61565106, 61565112, 61565119, 61565125, 61382207, 61393990, 61417407, 61487578, 61487579, 61487580, 61487581, 61495237, 61516921, 61516922, 61525230, 61538057, 61543828, 61565116, 61565124, 61582745, 61394050, 61417406, 61487582, 61487583, 61487584, 61500251, 61516927, 61525227, 61525228, 61565109, 61565121, 61402292, 61487585, 61516917, 61525229, 61565122
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
  • Descripción del producto
    CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • Descripción del producto
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
  • Modelo / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Descripción del producto
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
  • Manufacturer
  • Modelo / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Descripción del producto
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" || Soft Drain , 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-030-05.
  • Manufacturer
  • Modelo / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Descripción del producto
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-040-05.
  • Manufacturer
  • Modelo / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Descripción del producto
    Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-050-05.
  • Manufacturer
258 más