Device Recall Zimmer

  • Modelo / Serial
    lot no.: 61893774 61968082 62153448 62296426 62296426N 61983672 62153447 61827280 61920741 61964034 62108027 62108029 62153449 61835479 61878730 61878732 61940068 61940069 62121105 62121106 62121107 62121108 61621138 61878733 61929350 61940070 61940071 62086349 62086350 62086351 62086353 62086355 62086356 62153450 61763506 61878734 61878735 61940072 62121116 62121117 62121118 62121119 61878736 61929351 61940076 62121110 62121111 62121112 62121113 62103433 61597004 61597004N 61906259 61895931 61895932 61895933 61895935 61912972 61912975 61912976 61912977
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 60 consists of all product under product code: HSB and same usage: || Item no: || 225207055 RECON SCREW LG 5.5MM DIA || 225207555 RECON SCREW LG 5.5MM DIA || 225208055 RECON SCREW LG 5.5MM DIA || 225208555 RECON SCREW LG 5.5MM DIA || 225209055 RECON SCREW LG 5.5MM DIA || 225209555 RECON SCREW LG 5.5MM DIA || 225210055 RECON SCREW LG 5.5MM DIA || 225210555 RECON SCREW LG 5.5MM DIA || 225211555 RECON SCREW LG 5.5MM DIA || 225212055 RECON SCREW LG 5.5MM DIA || 225213055 RECON SCREW LG 5.5MM DIA || Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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 # 60869302 and lot # 60963801
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • Modelo / Serial
    lot #'s: 60544910, 60750863 and 60902482
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • Modelo / Serial
    lot #'s: 60806992 and 60921166
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • Modelo / Serial
    lot #'s: 60636760, 60723667 and 60896770.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item # 00-1179-024-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • Modelo / Serial
    lot #'s: 60530181, 60587803, 60739782, 60826082, and 60963803.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Standard 9 inch, Item # 00-1179-025-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
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