Device Recall Panacryl Absorbable Suture 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    34682
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0907-06
  • 사례 시작날짜
    2006-02-16
  • 사례 출판 날짜
    2006-05-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2006-12-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    suture - Product Code GAM
  • 원인
    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.
  • 조치
    Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture.

Device

  • 모델명 / 제조번호(시리얼번호)
    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)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    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.
  • 제품 설명
    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

  • 제조사 주소
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • 제조사 모회사 (2017)
  • Source
    USFDA