Device Recall Zimmer

  • Modelo / Serial
    Item numbers: 00-8775-028-01; 00-8775-028-02; 00-8775-028-03;  00-8775-032-01; 00-8775-032-02; 00-8775-032-03;  00-8775-032-04; 00-8775-036-01; 00-8775-036-02; 00-8775-036-03; 00-8775-036-04; 00-8775-040-01; 00-8775-040-02; 00-8775-040-03; 00-8775-040-04.  Lot #'s:  2524205, 2527529, 2531817, 2543976, 2547030, 2522713, 2535758, 2541605, 2544263, 2538145, 2541613, 2524241, 2524242, 2535756, 2535757, 2538147, 2538184, 2543978, 2543979, 2549572, 2553888, 2557023, 2559372, 2524199, 2524200, 2527535, 2527536, 2527537, 2532038, 2535759, 2535765, 2535766, 2538148, 2538149, 2538152, 2538186, 2545261, 2546980, 2548230, 2551239, 2554875, 2557033, 2524204, 2527538, 2527539, 2538153, 2538189, 2544167, 2551250, 2556148, 2557156, 2535768, 2538190, 2541618, 2544169, 2552353, 2524244, 2524260, 2524261, 2527546, 2527547, 2531818, 2535769, 2535770, 2538165, 2538167, 2538168, 2541619, 2541620, 2544176, 2544177, 2547032, 2552354, 2552365, 2522849, 2524201, 2524202, 2524203, 2527548, 2527549, 2527590, 2531774, 2531815, 2531816, 2538169, 2538170, 2538171, 2538173, 2538175, 2538176, 2541852, 2541853, 2544189, 2544190, 2544191, 2548154, 2552367, 2552368, 2554887, 2554888, 2556180, 2557159, 2557170, 2524262, 2524263, 2527592, 2527593, 2531819, 2535772, 2538177, 2538178, 2538180, 2541866, 2544196, 2545262, 2548170, 2552369, 2556181, 2538191, 2541868, 2524271, 2527594, 2538194, 2538195, 2541869, 2541910, 2541911, 2544198, 2557173, 2568103, 2568982, 2582562, 2583925, 2590223, 2591046, 2591047, 2596627, 2597821, 2600144, 2602748, 2615192, 2617666, 2618635, 2621751, 2623054, 2632524, 2633562, 2635942, 2638898, 2641867, 2642795, 2645303, 2647759, 2651994, 2531222, 2538196, 2538197, 2541912, 2541913, 2544253, 2545245, 2558285, 2566263, 2566672, 2568104, 2570197, 2576875, 2576876, 2583926, 2591048, 2591049, 2596628, 2596954, 2596960, 2599455, 2602729, 2605035, 2606707, 2608757, 2614031, 2616153, 2618045, 2620408, 2622735, 2623070, 2628694, 2629838, 2633563, 2634788, 2637813, 2638899, 2639802, 2641868, 2642796, 2642797, 2645304, 2648615, 2651105, 2651106, 2524272, 2527606, 2538198, 2541914, 2541925, 2544254, 2567876, 2568983, 2573850, 2583927, 2591050, 2591051, 2597822, 2602735, 2606708, 2615193, 2618046, 2620409, 2627501, 2629839, 2632525, 2634789, 2638910, 2639803, 2642798, 2645305, 2647760, 2538199, 2538200, 2541926, 2541927, 2541928, 2544260, 2545246, 2573846, 2583928, 2591076, 2597823, 2601623, 2610484, 2617667, 2622736, 2627924, 2629840, 2634790, 2639808, 2639809, 2642799, 2646184, 2647761, 2648617, 2651108
  • 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
    Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.
  • 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
    Lots 00111581, 61229463, 61232451, 61284938 and 61284939.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Descripción del producto
    Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-03. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • Modelo / Serial
    Workstation serial numbers SP014, SP015, SP019 through SP022, SP025 through SP033, SP035, SP038, SP039, SP043, SP044, SP047, SP049, SP052, SP057, SP058, SP060, SP061, SP062, SP064, SP065, SP069, SP072, SP074 through SP083, SP089, SP090, SP091, SP093, SP094, SP098, SP099, SP121, SP124, SP125, SP127, SP128, SP131 through SP135, SP151 through SP154, SP157, SP175, SP176, SP183, SP184, SP185, SP190 and SP198.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.
  • Manufacturer
  • Modelo / Serial
    Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Ohio, Canada and France.
  • Descripción del producto
    Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
  • Manufacturer
  • Modelo / Serial
    Lot 61042477.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide, Korea and Switzerland.
  • Descripción del producto
    Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.
  • Manufacturer
  • Modelo / Serial
    All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248, 60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670, 60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449, 60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036, 60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387, 61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247, 61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179, 61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170, 61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and 61329266.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
  • Descripción del producto
    Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. || The product is used as an implant for knee replacement.
  • Manufacturer
258 más