Ethicon, Inc.: 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.

Recall number

Z-0907-06

Recalling firm

Ethicon, Inc.

Product

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.

Status

Terminated

Initiated

2006-02-16

Posted

2006-05-27

Terminated

2006-12-07

Reason

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.

Root cause

Other

Action

Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture.

Quantity

1,061,712 sutures

Distribution

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.

Lot, serial or model codes

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)

510(k) numbers

["K964345","K974299"]

PMA numbers

not on file

Product code

GAM

Firm FEI

2210968

Firm city

Somerville

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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