Device Recall Zimmer

  • Modelo / Serial
    lot no.: 61873094 61895696 61905916 61905918 61905920 61919766 61919767 61919768 61956249 61956250 61981202 61981204 61999375 62027331 62060784 62074467 62074469 62096750 62096751 62133740 62164984 62168517 62171693 62171694 62171696 62174936 62205101 62213332 62213333 62220943 62345691 62345692 62345693 62345694 62352447 62352450
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 48 consists of all product under product code: JWH and same usage: || Item no: || 597206526 NEXGEN ALL-POLY PATELLA, || for use in total knee arthroplasty
  • 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
    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
  • 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
  • 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
  • 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
  • Modelo / Serial
    Item numbers: 19.32.05; 19.32.06; 19.32.08;  Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398
  • Clasificación del producto
  • 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
  • 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
  • Modelo / Serial
    Item No. 00-5852-052-10; Lot 62866438
  • Clasificación del producto
  • 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
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