Devices

Device Recall Zimmer

  • Modelo / Serial
    Item numbers: 19.32.05; 19.32.06; 19.32.08;  Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿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
    Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
  • Manufacturer
    Zimmer Gmbh
  • 1 Event

Fabricante

Zimmer Gmbh
  • Dirección del fabricante
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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

Device Recall Zimmer PERSONA
  • Modelo / Serial
    Item No. 42-5299-001-00 Affected Lots: 56572679; 56573170; 56574318; 56575056; 56572918; 56573378; 56574538; 56575057; 56572975; 56573379; 56574540; 56575058; 56572978; 56574123; 56574618; 56575059; 56572981; 56574124; 56574619; 56575060; 56572982; 56574223; 56574620; 56575061; 56573071; 56574291; 56574629; 56575062; 56573115; 56574292; 56574630; 56575065; 56573116; 56574316; 56574631; 56575080; 56573154; 56574317; 56575018
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.
  • Descripción del producto
    Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer
  • Modelo / Serial
    Item numbers: 01.01012.384; 01.01012.385; 01.01012.386; 01.01012.387; 01.01012.388; 01.01012.444; 01.01012.445; 01.01012.446; 01.01012.447; 01.01012.448   Lot #'s: 2551762, 2542690, 2542691, 2543993, 2544892, 2544893, 2551930, 2551931, 2557054, 2558475, 2559787, 2563363, 2564657, 2568082, 2539887, 2540911, 2544894, 2544895, 2545830, 2545831, 2545832, 2545833, 2547043, 2547807, 2548952, 2551330, 2551860, 2551861, 2554798, 2554799, 2554800, 2558476, 2558477, 2559788, 2561617, 2562662, 2563364, 2563385, 2565407, 2566564, 2567294, 2542692, 2542693, 2544896, 2547044, 2548953, 2551932, 2553210, 2556029, 2559603, 2563386, 2539888, 2540926, 2548954, 2553419, 61487633, 61487634, 61636015, 61495961, 61495962, 61495963, 61562431, 61577697, 61608436, 61562432, 61577709, 61487635, 61562448
  • Clasificación del producto
    Orthopedic Devices
  • 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 - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
  • Manufacturer
    Zimmer Gmbh
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
    Orthopedic Devices
  • 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
    Zimmer Gmbh
Device Recall Zimmer
  • Modelo / Serial
    Item No. 00-5852-052-10; Lot 62866438
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the state of TX
  • Descripción del producto
    Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem || Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
  • Manufacturer
    Zimmer, Inc.
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
    Orthopedic Devices
  • 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
    Zimmer Gmbh
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