Class 2 Device Recall

• Date Initiated by Firm: July 15, 2010
• Date Posted: October 01, 2010
• Recall Status: Terminated on October 19, 2011
• Recall Number: z-2640-2010
• Recall Event ID: 56652
• Product Classification: Instrument, Ultrasonic Surgical - Product Code LFL
• Product: Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
• Code Information: 06I0599, 08I0973, 07J0790, 04K0294, 07C0671, 09B1031, 04G0254, 04H0259, 06I0601, 08D0887, 06B0472, 05G0373, 07F0718, 07G0738, 05J0421, 08D0888, 04L0315, 05G0375, 04L0311, 06C0484, 04A0209, 08I0974, 04A0208, 03L0197, 07I0787, 09B1028, 07L0822, 06B0470, 04G0252, 05I0401, 09B1026, 06B0467, 06G556, 03I0166, 05E0378, 05E0351, 05J0422, 04D0237, 05L0448, 08C0872, 07E0703, 07L0825, 08L0998, 07K0811, 08G0937, 05J0423, 06B0468, 08D0885, 08D0891, 08G0935, 08G0936, 07E0700, 07E0701, 06H0576, 04D0230, 04D0231, 06I0603, 07B0655, 07B0653, 08G0932, 04F0242, 04I0262, 08D0889, 03I0168, 08B0855, 07K0807, 08A0847, 08B0858, 06F0543, 07F0721, 07F0719, 07F0720, 07F0732, 04K0293, 04I0279, 06G0569, 06K0618, 06I0586, 04K0292, 05A0341, 07K0808, 07H0766, 07H0767, 07E0714, 04H0261, 05L0444, 05L0446, 07K0810, 07K0812, 07K0813, 07L0830, 08D0893, 07E0705, 06H0574, 06H0577, 06H0578, 06I0588, 08I0985, 08I0972, 09B1035, 08F0914, 07F0731, 04G0253, 07F0722, 07K0805, 04K0295, 07C0672, 07K0806, 08B0857, 07B0652, 07G0739, 05E0379, 07I0785, 07I0786, 06G0567, 04I0282, 08E0907, 07I0788, 07I0789, 04I0271, 06C0488, 06C0487, 04B0194, 08D0886, 06B0473, 06C0486, 09B1027, 04H0260, 06A0456, 06E0532, 07C0670, 06I0602, 06C0489, 06E0530, 03L0196, 04J0283, 06G0568, 03I0170, 06B0475, 03I0171, 08G0934, 07F0717, 08F0925, 08A0843, 03H0165, 06G557, 06G555, 08L0999, 06A0459, 06A0460, 06A0461, 09A1008, 09A1009, 09A1010, 09A1016, 07L0827, 07L0828, 07L0829, 08C0871, 08C0873, 08C0874, 08C0875, 09B1034, 08D0890, 09C1051, 06D0511, 09E1069, 09E1070, 09E1071, 09E1085, 09E1086, 08E0895, 08E0896, 08F0926, 08F0927, 08F0928, 08F0929, 08F0930, 08G0938, 06H0573, 07K0623, 07G0735, 07G0736, 06H0575, 06I0589, 06K0621, 03G0162, 04D0236, 05L0447, 06D0510, 07H0764, 07H0765, 06G558, 06D0512, 07L0824, 09A1017, 08D0877, 06H0572, 06H0571, 06C0490, 06H0579, 08B0859, 08B0854, 08I0970, 06B0469, 06F0545, 09B1032, 09B1033, 08D0892, 09C1049, 09C1050, 07E0704, 08E0905, 08E0906, 06C0491, 07E0699, 06I0590, 05L0445, 07H0763, 06C0492, 07K0622, 07E0702, 06G0554, 07G0740, 08F0915, 07J0791, 07C0669, 06E0534, 07G0741, 06I0587, 03L0195, 06I0600, 05F0381, 07B0656, 08B0860, 04L0313, 07L0823, 08A0842, 08G0933, 05G0374, 07G0742, 06K0620, 07G0747, 07D0688, 04I0272, 05G0390, 05I0400, 05H0397, 06C0485, 08B0856, 07F0716, 07D0684, 06F0544, 08F0916, 07K0809, 03G0163, 06B0474, 05G0389, 07A0643, 08F0912, 05F0380, 02#0065, 04G0251, 03I0172, 04I0273, 04F0244, 07L0832, 08I0984, 09B1025, 06B0471, 08A0848, 06E0531, 06E0533, 08E0908, 08G0939, 04F0245, 06J0604, 07G0743, 07G0745, 05G0396, 05G0395, 05H0398, 06H0570, 07D0685, 02%0075, 02%0076, 04L0312, 07D0687, 05G0392, 03D0134, 02I0109, 02I0110, 03I0169, 07G0748, 03E0161, 07B0657, 06A0457, 04I0280, 04I0281, 04K0291, 07G0746, 08G0931, 07B0654, 07F0730, 06K0619, 05A0342, 05G0391, 03I0167, 04C0223, 06F0542, 03H0164, 08I0971, 08F0913, 06J0617, 03G0148, 03G0149, 03G0150, 04C0222, 04K0310, 04A0205, 04K0309, 03I0173, 02L0119, 03A0124, 02#0057, 02G0092, 01(0010, 01J0024, 02!0041, 01+0028, 01,0034, 01,0032, 01,0033, 09B1030, 09C1047, 09J1103, 09I1104, 09I1105, 09I1106, 09L1107, 09L1108, 09L1109, 09L1111, 09L1112, 09L1113, 09L1129, 09L1130, 09L1131, 09L1132, 09L1133, 09L1134, 09L1135, 09L1136, 09L1137, 09L1138, 09L1139, 09L1140, 09L1141, 09L1142, 09L1143, 09L1144, 09L1145, 09L1146, 09L1147, 09L1152, 09L1153, 09L1154, 09L1155, 09I1094, 09H1076, 08H0955, 09E1079, 02L0120, 09I1096, 02L0114, 09I1100, 09I1099, 09I1102, 02A0038, 03I0153, 03L0190, 09A1024, 09D1053, 03A0133, 06F0546, 06F0547, 04D0232, 05D0336, 05B0344, 09I1101, 02E0073, 09L1110, 09J1126, 04C0224, 04D0235, 04F0241, 04F0243, 04L0314, 07L0833, 09L1151, 09L1148, 09L1149, 09L1150, 09J1116, 09J1117, 09J1118, 09J1119, 09J1120, 09J1121, 09J1122, 09J1123, 09J1124, 09J1125, 09J1127, 09C1045, 07G0744, 07G0749, 06A0458, 05I0399, 07D0683, 07D0686, 07G0756, 09E1019, 09C1041, 09C1042, 02!0039, 02F0080, 02%0074, 01(0002, 01+0026, 0037, 02I0105, 03F0143, 04A0210, 0323, 0368, 06A0465, 08I0969, 07L0831, 09A1018, 09A1023, 06B0477, 06B0478, 09I1114, 09I1115, 07G0733, 07G0734, 08G0940, 08I0975, 07I0782, 07I0781, 09A1007, 09B1029, 08A0845, 06B0476, 09B1036, 09B1037, 09B1038, 09C1048, 08C0876, 08C0870, 07H0770, 06E0529, 08E0902, 08H0956, 07H0771, 07H0772, 04B0216, 09A1021, 09I1091, 07C0668, 06G0566, 07B0651, 07H0762, 05I0407, 02$0071, 08G0941, 06J0605, 01+0029, 01+0030, 07I0783, 08J0986, 08J0994, 09C1039, 09C1040, 08E0904, 08E0903, 07I0784, 04F0247, 04E0234, 04E0233, 04F0246, 04F0248, 04L0317, 04L0318, 04J0284, 04J0285, 02F0078, 02F0079, 03C0125, 03#0126, 03D0156, 03D0157, 03D0158, 08K0996, 08C0869, 08H0951, 05G0394, 05F0362, 02B0055, 05A0343, 05K0434, 06F0551, 02E0072, 03E0159, 04C0217, 05K0433, 07J0799, 07K0826, 09A1020, 08H0952, 07E0624, 06I0591, 05E0352, 05G0377, 02B0053, 08H0959, 08A0839, 08I0966, 08I0977, 09D1057, 08F0910, 07C0667, 07B0658, 05I0408, 07G0750, 09H1065, 06E0539, 06E0527, 08F0911, 05I0413, 07E0706, 02L0113, 07F0725, 04D0225, 05L0440, 09D1059, 03A0121, 07A0644, 05H0385, 06D0513, 05A0335, 07H0774, 04K0297, 07D0691, 07E0696, 09H1090, 07I0780, 07G0753, 02G0089, 08I0980, 08H0950, 07F0724, 02B0052, 04G0263, 04K0302, 06J0606, 01(0007, 08L1006, 05F0359, 07C0678, 07C0666, 09E1088, 03K0186, 02!0046, 07L0836, 05A0328, 02!0043, 02$0067, 02B0054, 03K0187, 02)0108, 08C0865, 01J0018, 08I0981, 05F0366, 04G0264, 05K0431, 05K0432, 03+0184, 07G0757, 07K0815, 09E1080, 04A0201, 05L0439, 05E0349, 07E0713, 02F0084, 06B0480, 08H0949, 06L0628, 08H0954, 06G0561, 05F0363, 04C0219, 06L0629, 06L0634, 02F0077, 07J0793, 08A0840, 08J0989, 05J0424, 04L0325, 07C0663, 04K0303, 07D0682, 07H0775, 06E0526, 05H0383, 08H0953, 03G0152, 04K0305, 10B1166, 07G0759, 07E0711, 04G0250, 06L0633, 06H0580, 09D1061, 01(0006, 05H0406, 08L1003, X7L0821, 07B0661, 07G0752, 07I0779, 05G0376, 09H1073, 09G1063, 01)0012, 02G0090, 05F0354, 02K0112, 03J0174, 07L0820, 08E0898, 06G0560, 05E0350, 06I0598, 06E0525, 07D0681, 01J0022, 04B0211, 06A0449, 08F0921, 05F0371, 08L1002, 03L0189, 04J0288, 05I0414, 05F0358, 07G0754, 02H0104, 06C0497, 08C0882, 04K0298, 07C0675, 04I0278, 08I0982, 07J0798, 08E0901, 05H0403, 05H0388, 07F0729, 04K0306, 08J0991, 07I0777, 07E0712, 08C0866, 08I0968, 03J0178, 03K0179, 06B0479, 06A0450, 05A0329, 06L0641, 08H0947, 05D0345, 02F0085, 08C0867, 05L0441, 07J0795, 06G0553, 07F0727, 08H0958, 06C0508, 04I0277, 07E0709, 09E1082, 08E0900, 06H0583, 06L0635, 02G0093, 07J0792, 06E0524, 04A0198, 05J0416, 06E0541, 06D0516, 05A0327, 05F0365, 09A1013, 06H0585, 04I0275, 04K0296, 02H0103, 03J0175, 08C0878, 09H1075, 04G0257, 07J0797, 04H0269, 07G0758, 02G0096, 05I0410, 02F0081, 02G0094, 06B0482, 05K0438, 06C0494, 07I0776, 09A1014, 07L0834, 01J0025, 05D0338, 09D1055, 08H0946, 06F0549, 06F0550, 09D1058, 05F0357, 05J0417, 05H0387, 07J0803, 07D0680, 01,0031, 06J0610, 06D0514, 06D0515, 01J0021, 05E0355, 08H0948, 06L0636, 08I0965, 02!0040, 10B1168, 02H0102, 05D0340, 07D0679, 06L0630, 01(0008, 06D0509, 02B0049, 02#0058, 02$0068, 02H0101, 07C0673, 09H1074, 02B0051, 09G1046, 02!0042, 04A0204, 04K0300, 04K0301, 05F0367, 08B0861, 04H0270, 04K0304, 04J0289, 08J0992, 09A1012, 09H1072, 06L0637, 02I0106, 06J0615, 05H0386, 06L0642, 08J0990, 07D0693, 02$0069, 06G0552, 03K0181, 01+0027, 05F0356, 05D0339, 08J0988, 07B0650, 07J0802, 03C0138, 05H0404, 04A0203, 05K0435, 03C0136, 04G0258, 07G0755, 01)0011, 06A0464, 06L0627, 07A0647, 03F0132, 08L1001, 02H0100, 05I0409, 02K0111, 02B0056, 07G0760, 08C0879, 04L0321, 03A0122, 08A0851, 02!0044, 09E1084, 07K0804, 04B0213, 06H0582, 07A0646, 04B0199, 02F0088, 05F0364, 07E0698, 09H1066, 09H1089, 06L0631, 06J0609, 06J0607, 03G0145, 03L0193, 06A0451, 04D0227, 01(0003, 06G0563, 03L0192, 07F0723, 09D1060, 01J0023, 02I0107, 03C0137, 05K0430, 03K0182, 03K0183, 01,0035, 02F0083, 01J0020, 08G0944, 06B0481, 06I0596, 08I0967, 08H0960, 08D0883, 02B0050, 07E0708, 06A0454, 01,0036, 01(0005, 06A0453, 08I0964, 09H1077, 06C0495, 06H0584, 07E0707, 04F0240, 07J0796, 06J0612, 08C0880, 08G0943, 06A0466, 06G0559, 04G0249, 04H0267, 03F0142, 06B0483, 03J0176, 06A0455, 09H1067, 07I0778, 06L0625, 03J0177, 05H0382, 08F0917, 05A0334, 09E1087, 05J0418, 07J0801, 06G0565, 02F0086, 02B0048, 05D0346, 01(0009, 07K0816, 06I0593, 07L0835, 08H0957, 07B0660, 05E0353, 05E0348, 07L0819, 06J0611, 05J0427, 04L0324, 01(0004, 08G0945, 03L0191, 02$0066, 06G0562, 06G0564, 09I1097, 08I0979, 02G0095, 05I0412, 06E0537, 09D1054, 05H0402, 03B0128, 06D0517, 01)0014, 01J0016, 05J0420, 05H0384, 04J0287, 06I0592, 08F0918, 04L0322, 04K0299, 07E0710, 06C0503, 06C0507, 06D0522, 06C0501, 06E0535, 06D0520, 06L0640, 06C0506, 06C0499, 06E0536, 06D0521, 06C0504, 06D0518, 06C0505, 05L0443, 06E0538, 06C0500, 07C0676, 06D0519, 06C0498, 06L0639, 06C0502, 08F0920, 05J0426, 05F0369, 04A0207, 07D0690, 04C0218, 02F0082, 05J0428, 05D0347, 04C0221, 01J0017, 08A0841, 03F0131, 08B0853, 02B0047, 06L0638, 08B0863, 05L0442, 04H0265, 02F0087, 06F0548, 07C0674, 09A1011, 04D0229, 04B0215, 06E0540, 02G0098, 03B0127, 04C0220, 03B0129, 02G0097, 03G0151, 10B1162, 02C0062, 02C0063, 02#0060, 02#0061, 02#0064, 05K0437, 09G1044, 09E1083, 05F0372, 05I0411, 05A0326, 08L1000, 07D0692, 06I0597, 02$0070, 07D0689, 05A0333, 04K0307, 08A0849, 07G0761, 08F0924, 08L1005, 01)0015, 08E0897, 07C0664, 08I0983, 08B0852, 08J0993, 07F0726, 09H1068, 09A1015, 05H0405, 04C0200, 07G0751, 07K0817, 07K0818, 05J0425, 05J0419, 06J0613, 05A0331, 05F0360, 06C0496, 05I0415, 08E0899, 09E1081, 03G0146, 09D1056, 09A1022, 08F0923, 03K0180, 07J0794, 06I0595, 03G0144, 06E0528, 08B0864, 03G0147, 06I0594, 03K0185, 07D0694, 04J0290, 06C0493, 07J0800, 02#0059, 07K0814, 07L0837, 08C0881, 07E0715, 07D0695, 06J0614, 08L1004, 04D0228, 05A0330, 04K0308, 06D0523, 06L0632, 09G1043, 08G0942, 02H0099, 06A0462, 04G0255, 04G0256, 05K0436, 09D1062, 08J0987, 07B0649, 06J0608, 02!0045, 07H0773, 04B0214, 04B0212, 04I0274, 08I0963, 08I0978, 03A0123, 07B0662, 04H0268, 06A0452, 07C0665, 03C0139, 05A0332, 07C0677, 04F0238, 08A0838, 06A0463, 04L0320, 07A0645, 07B0648, 04A0202, 01J0019, 05K0429, 03F0141, 07B0659, 01)0013, 09I1098, 04J0286, 01(0001, 04F0239, 03L0188, 06H0581, 02G0091, 07E0697, 10B1167, 09G1064, 04I0276, 04A0206, 04D0226, 09I1095, 05D0337, 08F0919, 03B0130, 07G0737, 04H0266, 07F0728, 08A0850, 05F0370, 08B0862, 05F0361, 08D0884, 08F0922, 06L0626, 10B1172, 10B1170, 10B1159, 10B1165, 10B1164, 10B1169, 10B1160, 10B1173, 03B0140, 10B1157, 10B1163, 10B1161, 10B1174, 10B1158, 10B1171, 08A0844, 02K0115, 02K0116, 02K0117, 02K0118, 04L0319, 04L0316, 03H0135, 05G0393, 07H0768, 07H0769, 08J0995, 08E0909, 09G1078, 09I1092, 09I1093 and 03E0160.
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E. Milham Ave.; Kalamazoo MI 49001
• For Additional Information Contact: Jennifer Mars; 269-323-7700
• Manufacturer Reason for Recall: Stryker Instruments acquired the Sonopet Ultrasonic Surgical System from Mutoh co. Ltd on 3/29/2010. Stryker determined that the Sonopet consode did not meet the IEC-60601-1 standard. Stryker decided to recall the Sonopet consode.
• FDA Determined Cause: Device Design
• Action: The firm to send URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to customers dated 7/15/2010. The customers were instructed to continue to use the device. Stryker technicians were dispatched to replace a board with a new board.
• Quantity in Commerce: 1161
• Distribution: Wordwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.