Retiro De Equipo (Recall) de Device Recall Panacryl Absorbable Suture

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ethicon, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    34682
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0907-06
  • Fecha de inicio del evento
    2006-02-16
  • Fecha de publicación del evento
    2006-05-27
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2006-12-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    suture - Product Code GAM
  • Causa
    The unique absorption profile of panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.
  • Acción
    Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture.

Device

  • Modelo / Serial
    All codes.  MH2548, MH2549, MH2550, MH2744, MH2745, MH7477, MH7478, MH7479, MH7481, MH7482, MH7495, MH7636, MH7637, MH7638, MH7703R, MH7708, MH7709, MH7710, MJ2180, MJ2181, MJ2182, MJ2213, MJ2214, MJ2739, MJ2740, MJ2741R, MJ2742R, MJ2743R, MJ2789, MJ7119, MJ7120, MJ7121R, MJ7330, MJ7331, MJ7332, MJ7363, MJ7364, MJ7365, MJ7706, MJ7707, MJ7826, MJ7827, MJ7886, MJ7900R, MJ7901R, MJ7902R, MJ7969, MJ7970, MJ7971, MJ7975, MJ7976, MJ7978, MJ7979, MJ7980, MJ7981, MJ7982, MJ7983, MJ7984, MJ7985, MJ7986, MJ7990, MJ7991, MJ7993, MJ7994, MJ8013, MJ8018, MJ8019, MJ8020R, MJ8021, MJ8022R, MJ8023R, MK2185, MK7186, MK7269, MK7343, MK7344, MK7376, MK7468, MK7469, MK7471, MK7472, MK7473, MK7474, MK7477, MK7478, MK7479, MK7480R, MK7481, MK7482, MK7483, MK7484, MK7486, MK7487, MK7501, MK7502, MK7503, MK7504, MK7505, MK7506, MK7507, MK7564, MK7565, MK7566, MK7567, MK7634, MK7822, MK7824, MK8014, MK8015, MK8016, MK8017, MK8023, MK8024, ML2020, ML2191, ML2941, ML7175R, ML7250, ML7424, ML7430, ML9750, ML9767, MM2056, MM2080, MM2581, MM2797, MM2798, MM2799, MM2800, MM2803, MM2804, MM2807, MM2810, MM7207, MM7589, MM7677, MM9729, MM9740, MM9750, MM9755, MM9891, MM9896, MM9897, MP2094, MP2403, MP2426, MP2474, MP2551, MP2601, MP2602, MP2603, MP2817, MP2840, MP2841, MP7251, MP7252, MP7351, MP7367, MP7644, MP7704, MP7761, MP7828, MP7829, MP7849, MP9702, MP9734, MP9759, MP9762, MP9772, MP9876, MP9916, PA2258, PA2259, PA2260, PA7254, PA7255, PA7256, PA7381, PA7400, PA7700, PA7702, PA7703, PA7742, PA7806, PA7807, PA7924, PA9717, PA9719, PA9729, PA9730, PA9749, PA9771, PA9776, PA9872, PA9873, PA9897, PB2421, PB2473, PB2474, PB2483, PB2545, PB2548, PB2555, PB2672, PB2673, PB2718, PB2755, PB2774, PB2795, PB2838, PB2861, PB2862, PB2874, PB7150, PB7345, PB7346, PB7633, PB7634, PB7637, PB7638, PB7639, PB7640, PB7641, PB7772, PB7773, PB7909, PB7910, PB9711, PB9712, PB9729, PB9739, PB9741, PB9743, PB9887, PB9926, PB9944, PB9951, PB9984, PC2042, PC2043, PC2057, PC2066, PC2104, PC2408, PC2459, PC2471, PC2481, PC2508, PC2509, PC2537, PC2598, PC2805, PC2814, PC2815, PC2829, PC2866, PC2924, PC2925, PC7126, PC7149, PC7323, PC7324, PC7325, PC7326, PC7327, PC7329, PC7392, PC7393, PC7394, PC7395, PC7770, PC7864, PC7904, PC7905, PC9700, PC9717, PC9756, PC9757, PC9776, PC9790, PC9792, PC9793, PC9803, PC9963, PC9966, PC9967, PD2091, PD2092, PD2183, PD2418, PD2420, PD2446, PD2463, PD2480, PD2481, PD2482, PD2494, PD2721, PD2723, PD2772, PD2774, PD2796, PD7290, PD7291, PD7331, PD7428, PD7544, PD7697, PD7698, PD7699, PD7732, PD7745, PD7746, PD7747, PD7767, PD7799, PD7899, PD9711, PD9719, PD9724, PD9725, PD9732, PD9743, PD9754, PD9755, PD9763, PD9766, PD9767, PD9889, PD9899, PD9913, PD9914, PD9933, PE2073, PE2185, PE2435, PE2552, PE2553, PE2558, PE2559, PE2586, PE2587, PE2603, PE2607, PE2612, PE2619, PE2896, PE2896S, PE2980, PE7565, PE7566, PE7567, PE7600, PE7627, PE7685, PE7686, PE7830, PE7879, PE7879S, PE9712, PE9730, PE9742, PE9754, PE9766, PE9817, PE9818, PE9825, PE9830, PG2011S, PG2132, PG2133, PG2159, PG2160, PG2161, PG2413, PG2451, PG2454, PG2456, PG2554, PG2624, PG2625, PG2629, PG2635, PG2636, PG2661, PG2662, PG2663, PG2694, PG2695, PG2702, PG2703, PG2780, PG2977, PG7131, PG7132, PG7383, PG7384, PG7474, PG7475, PG7488, PG7595, PG7620, PG7621, PG7717, PG7754, PG7755, PG7851, PG7852, PG7998, PG9708, PG9710, PG9730, PG9744, PG9748, PG9749, PG9750, PG9753, PG9757, PG9758, PG9849, PG9850, PG9884, PH2015, PH2410, PH2414, PH2423, PH2424, PH2427, PH2428, PH2429, PH2430, PH2431, PH2442, PH2446, PH2447, PH2449, PH2451, PH2477, PH2481, PH2742, PH2747, PH2774, PH2981, PH7180, PH7389, PH7390, PH7407, PH7408, PH9734, PH9735, PH9751, PH9756, PH9886R, PH9903, PJ2036, PJ2036D, PJ2037, PJ2037D, PJ2078, PJ2078D, PJ2220, PJ2221, PJ2413, PJ2418, PJ2419, PJ2420, PJ2422, PJ2430, PJ2478, PJ2479, PJ2484, PJ2485, PJ2500, PJ2505, PJ2508, PJ2631, PJ2650, PJ2650D, PJ2655, PJ2679, PJ2680, PJ2681, PJ2681D, PJ2682, PJ2682D, PJ2749, PJ2749D, PJ2750, PJ7245, PJ7246, PJ7247, PJ7255, PJ7255D, PJ7259, PJ7259D, PJ7440, PJ7549, PJ7577, PJ7578, PJ7584, PJ7584D, PJ7588, PJ7589, PJ7590, PJ7599D, PJ7599S, PJ7600, PJ7600D, PJ7601, PJ7606, PJ7606D, PJ7695, PJ7710, PJ9703, PJ9704D, PJ9704S, PJ9705, PJ9711, PJ9720, PJ9740, PJ9855, PJ9856, PJ9857, PJ9860, PJ9861, PJ9861D, PJ9866, PJ9866D, PJ9867, PJ9901, PJ9902, PK2198, PK2199, PK2244, PK2292, PK2405, PK2407, PK2409, PK2414, PK2441, PK2501, PK2522, PK2578, PK2583, PK2590, PK2644, PK2650, PK2654, PK2672, PK2689, PK2704, PK2705, PK2707, PK2734, PK2746, PK2748, PK2790, PK2803, PK2804, PK2806, PK2807, PK2837, PK7354, PK7381, PK7383, PK7384, PK9715, PK9715D, PK9717, PK9718, PK9720, PK9721, PK9733, PK9744, PK9746, PK9746D, PK9747, PK9748, PK9763, PK9782, PK9783, PK9784, PK9850, PK9851, PK9867, PK9885, PL2099, PL2196, PL2196D, PL2197, PL2197D, PL2198, PL2199, PL2199D, PL2200, PL2200D, PL2407, PL2412, PL2417, PL2417D, PL2418, PL2424, PL2424D, PL2448, PL2449, PL2505, PL2534, PL2538, PL2539, PL2572, PL2583, PL2597, PL2597D, PL2598, PL7126, PL7510, PL7594, PL7595, PL7705, PL7706, PL7799, PL7799D, PL9702, PL9709, PL9710, PL9713, PL9741, PL9741D, PL9745, PL9746, PL9756, PL9820, PL9837, PL9861, PM2071, PM2072, PM2140, PM2142, PM2423, PM2424, PM2465, PM2515, PM2762, PM2763, PM2764, PM7259, PM7448, PM7449, PM7450, PM7533, PM7534, PM7763, PM7763D, PM7764, PM7764D, PM9702, PM9704, PM9715, PM9717, PM9732, PM9734, PM9747, PM9748, PP2048, PP2410, PP2491, PP2536, PP2576, PP2578, PP2715, PP7163, PP7183, PP7184, PP7408S, PP7453, PP7454, PP9707, PP9708, PP9722, PP9723, PP9724, PP9735, PP9750, PP9835, QA2074, QA2075, QA2174, QA2236, QA2311, QA2413, QA2455, QA2486, QA2486D, QA2487, QA2491, QA2576, QA2590, QA2598, QA2609, QA2613, QA2636, QA7249, QA7250, QA7251, QA7956, QA7997, QB2040, QB2041, QB2075D, QB2075S, QB2076S, QB2087, QB2088, QB2121, QB2393, QB7120, QB7120D, QB7121, QB7122, QB7122D, QB7257, QB7703, QB7704, QB7854, QB7973, QB7974, QB9005, QB9006, QB9008, QB9009, QB9033, QB9047, QB9109, QB9134, QB9140, QB9269, QB9272, QB9282, QB9282D, QB9294, QB9340, QB9341, QB9344, QB9345, QB9347, QB9348, QB9373, QB9373D, QB9395, QB9405, QB9406, QB9415, QC2008, QC2015, QC2093, QC2121, QC2267, QC2294S, QC2468, QC2469, QC7139, QC7140, QC7141, QC7142, QC7161, QC7240, QC7241, QC7242, QC7324, QC8025, QC8026, QC9002, QC9004, QC9012, QC9089, QC9095, QC9102, QC9135, QC9252, QC9253, QC9256, QC9257, QC9264, QD2063S, QD2211, QD7624, QD7630, QD7752, QD9002, QD9021, QD9026, QD9029, QD9081, QD9093, QD9093D, QD9095, QD9111, QD9119, QD9120, QD9214, QD9251, QE2132, QE2402, QE2403, QE2404, QE7324, QE7655, QE7828, QE7829, QE9014, QE9016, QE9028, QE9029, QE9043, QE9136, QE9204, QE9233, QE9272, QG2412, QG2424, QG2439, QG2567, QG2568, QG7919, QG8133, QG9067, QG9096, QG9108, QG9130, QG9382, QG9393, QG9425, QG9428, QG9510, QH2040, QH2252, QH7484, QH7899, QH7900, QH7916, QH7918, QH7919, QH7920, QH7921, QH9006, QH9015, QH9017, QH9019, QH9021, QH9022, QH9039, QH9040, QH9041, QH9054, QH9055, QH9056, QH9066, QH9067, QH9073, QH9089, QH9093, QH9105, QH9107, QH9123, QH9141, QH9147, QH9184, QH9217, QH9437, QH9441, QH9446, QJ2017, QJ2263, QJ7337, QJ7504, QJ7614, QJ7938, QJ7976, QJ7977, QJ7978, QJ8014, QJ8015, QJ8033, QJ9004, QJ9019, QJ9033, QJ9058, QJ9059, QJ9075, QJ9081, QJ9082, QJ9135, QJ9136, QJ9161, QJ9162, QJ9195, QJ9208, QJ9252, QJ9275, QJ9357, QJ9366, QK2087, QK2234, QK2235, QK2258, QK2447, QK2456, QK2469, QK2475, QK7504, QK7571, QK7581, QK7592, QK7643, QK7644, QK8012, QK8209, QK8236, QK8257, QK8258, QK9016, QK9066, QK9067, QK9077, QK9088, QK9089, QK9115, QK9119, QK9120, QK9141, QK9152, QK9154, QK9169, QK9213, QK9215, QK9216, QK9248, QK9256, QK9257, QK9258, QK9259, QK9263, QK9280, QK9281, QK9315, QK9371, QK9399, QK9411, QK9427, QL2459, QL2462, QL2489, QL7504, QL7505, QL7703, QL7960, QL7961, QL8056, QL9026, QL9061, QL9062, QL9081, QL9139, QL9157, QL9238, QL9273, QL9306, QL9309, QL9313, QL9324, QL9347, QL9348, QL9356, QL9364, QL9365, QL9373, QL9374, QL9375, QL9384, QL9385, QL9394, QL9397, QL9408S, QL9424, QM2021, QM2056, QM2057, QM2084, QM2085, QM7357, QM7448, QM7794, QM7983, QM9020, QM9073, QM9083, QM9092, QM9161, QM9162, QM9163, QM9177, QM9199, QM9204, QM9205, QM9230, QM9249, QM9251, QM9269, QM9312, QM9317, QM9352, QP2050, QP2056, QP2070, QP2072, QP2083, QP2110, QP2111, QP2126, QP2127, QP2157, QP2167, QP2169, QP2182, QP2185, QP2227, QP2228, QP2406, QP7568, QP7579, QP7775, QP7960, QP8017, QP8018S, QP9364, QP9392, QP9452, RA2026, RA2038, RA2414, RA2560, RA7572, RA8206, RA9010, RA9034, RA9035, RA9039, RA9040, RA9059, RA9063, RA9102, RA9141, RA9163, RA9164, RA9172, RA9223, RA9363, RA9390, RA9393, RA9426, RB2214, RB2215, RB2258, RB7053, RB7489, RB7687, RB7912, RB9015, RB9016, RB9063, RB9083, RB9087, RB9092, RB9094, RB9095, RB9096, RB9128, RB9150, RB9161, RB9175, RB9201, RB9206, RB9240, RB9251, RB9274, RB9283, RB9290, RC2163, RC2419, RC2420, RC7331R, RC7477, RC7498, RC7499, RC7644, RC8146, RC9009, RC9014, RC9015, RC9055, RC9073, RC9098, RC9123, RC9136, RC9137, RC9138, RC9144, RC9158, RC9173, RC9174, RC9189, RC9202, RC9226, RC9227, RC9233, RC9234, RC9246, RC9248, RC9258, RC9295, RC9299, RC9307, RC9324, RC9371, RC9373, RC9384, RC9385, RC9386, RD2090, RD2164, RD2173, RD2268, RD2304, RD2338, RD7914, RD7978, RD9045, RD9046, RD9047, RD9061, RD9117, RD9144, RD9156, RD9166, RD9196, RD9218, RD9230, RD9285, RD9286, RD9440, RD9443, RE2051, RE2084, RE2106, RE2107, RE2144, RE7827, RE8006, RE8108, RE8127, RE8303, RE8352, RE9010, RE9055, (End)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    There were 2202 customers in the US and 10 international customers. This product is no longer being marketed by Ethicon. Its last shipment was 7/1/2002. There are US Military and VA Hospitals included. All International customers are the J&J; Medical Products Distribution Ctrs located in Australia, Canada, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Taiwan, and Thailand.
  • Descripción del producto
    Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA