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U.S. Department of Health and Human Services

Class 2 Device Recall Sonopet Ultrasonic Aspirator Console

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 Class 2 Device Recall Sonopet Ultrasonic Aspirator Consolesee related information
Date Initiated by FirmJune 24, 2014
Date PostedAugust 07, 2014
Recall Status1 Terminated 3 on October 27, 2015
Recall NumberZ-2156-2014
Recall Event ID 68807
510(K)NumberK010309 
Product Classification Instrument, ultrasonic surgical - Product Code LFL
ProductSonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Code Information Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s: 01H0001 04G0251 06C0499 07G0748 08L1000 1018200054 1106200054 1202400194 1231200284 1320000054 01H0002 04G0252 06C0500 07G0749 08L1001 1018200064 1106200074 1202400204 1231200294 1320000064 01H0003 04G0253 06C0501 07G0750 08L1002 1018200074 1106200084 1202400214 1231200304 1320000074 01H0004 04G0254 06C0502 07G0751 08L1003 1018200084 1106700014 1202400224 1231200314 1320000084 01H0005 04G0255 06C0503 07G0752 08L1004 1018200094 1106700024 1202400234 1231200324 1320000094 01H0006 04G0256 06C0504 07G0753 08L1005 1018200104 1106800014 1202400244 1232000014 1320000104 01H0007 04G0257 06C0505 07G0754 08L1006 1018900014 1106800024 1203200214 1232000024 1320600014 01H0008 04G0258 06C0506 07G0755 09A1007 1018900024 1106800034 1203200224 1232000034 1320600024 01H0009 04G0263 06C0507 07G0756 09A1008 1018900034 1106800044 1203200234 1232000044 1320600034 01H0010 04G0264 06C0508 07G0757 09A1009 1018900044 1106800054 1203200244 1232000064 1320600044 01I0011 04H0259 06D0509 07G0758 09A1010 1018900054 1106800064 1203200254 1232000074 1320600054 01I0012 04H0260 06D0510 07G0759 09A1011 1018900064 1106800074 1203200274 1232000084 1320600064 01I0013 04H0261 06D0511 07G0760 09A1012 1018900074 1106800084 1203700954 1232600034 1321200214 01I0014 04H0265 06D0512 07G0761 09A1013 1018900084 1106800094 1203700964 1233400044 1321200224 01I0015 04H0266 06D0513 07H0762 09A1014 1018900094 1106800104 1203700974 1233400054 1321200234 01J0016 04H0267 06D0514 07H0763 09A1015 1018900104 1108100014 1203900024 1233400064 1321200244 01J0017 04H0268 06D0515 07H0764 09A1016 1019700014 1108100024 1204000044 1233900114 1321200254 01J0018 04H0269 06D0516 07H0765 09A1017 1019700024 1108100034 1204000054 1233900124 1321200264 01J0019 04H0270 06D0517 07H0766 09A1018 1019700034 1108100044 1204800264 1234000014 1321200274 01J0020 04I0262 06D0518 07H0767 09A1020 1019700044 1108100054 1205100514 1234000024 1321200284 01J0021 04I0271 06D0519 07H0768 09A1021 1019700054 1108100064 1205100524 1234000034 1321200294 01J0022 04I0272 06D0520 07H0769 09A1022 1020200104 1108100074 1205100534 1234000044 1321200304 01J0023 04I0273 06D0521 07H0770 09A1023 1020200114 1108100084 1205100544 1234000054 1321800744 01J0024 04I0274 06D0522 07H0771 09B1024 1020200124 1108400014 1205100554 1234000064 1321800754 01J0025 04I0275 06D0523 07H0772 09B1025 1020200134 1108400024 1205100564 1234000074 1321800764 01K0026 04I0276 06E0524 07H0773 09B1026 1020200144 1108400034 1205100574 1234000084 1321800774 01K0027 04I0277 06E0525 07H0774 09B1027 1020200154 1108400044 1205100584 1234800104 1321800784 01K0028 04I0278 06E0526 07H0775 09B1028 1020200164 1108400054 1205100594 1234800114 1321800794 01K0029 04I0279 06E0527 07I0776 09B1029 1020200174 1108400064 1205100604 1234800124 1322100374 01K0030 04I0280 06E0528 07I0777 09B1030 1020200184 1108400074 1205800064 1234800134 1322100384 01L0031 04I0281 06E0529 07I0778 09B1031 1020200194 1108400084 1205800074 1234800144 1322100394 01L0032 04I0282 06E0530 07I0779 09B1032 1021100014 1108400094 1205800084 1234800154 1322100404 01L0033 04J0283 06E0531 07I0780 09B1033 1021100024 1108400104 1205800094 1235401004 1322400484 01L0034 04J0284 06E0532 07I0781 09B1034 1021100034 1109500014 1205800104 1235600014 1322400494 01L0035 04J0285 06E0533 07I0782 09B1035 1021100044 1109500024 1206200574 1235600094 1322400504 01L0036 04J0286 06E0534 07I0783 09B1036 1021800764 1109500034 1206200584 1235600104 1322400514 02A0038 04J0287 06E0535 07I0784 09B1037 1021800774 1109500044 1206200594 1235600114 1322400524 02A0039 04J0288 06E0536 07I0785 09B1038 1021800784 1109500054 1206500014 1235600124 1322400534 02A0040 04J0289 06E0537 07I0786 09C1039 1021800794 1109500064 1206500024 1235600134 1323300144 02A0041 04J0290 06E0538 07I0787 09C1040 1021800804 1109500074 1206500034 1235600144 1323800014 02A0042 04K0291 06E0539 07I0788 09C1041 1022500014 1109500084 1206800484 1300900014 1323800024 02A0043 04K0292 06E0540 07I0789 09C1042 1022500024 1109500094 1206800494 1300900024 1323800034 02A0044 04K0293 06E0541 07J0790 09C1045 1022500034 1109500104 1206800504 1300900034 1323800064 02A0045 04K0294 06F0542 07J0791 09C1047 1022500044 1110400014 1206800514 1300900044 1324000214 02A0046 04K0295 06F0543 07J0792 09C1048 1022500054 1110400024 1206800524 1300900054 1324000224 02B0047 04K0296 06F0544 07J0793 09C1049 1022500064 1110400034 1206800534 1300900064 1324000234 02B0048 04K0297 06F0545 07J0794 09C1050 1023100014 1110400044 1206800544 1301600204 1324000244 02B0049 04K0298 06F0546 07J0795 09C1051 1023100024 1110400054 1207400154 1301600214 1324000254 02B0050 04K0299 06F0547 07J0796 09D1053 1023100034 1110400064 1207400164 1301600224 1324000264 02B0051 04K0300 06F0548 07J0797 09D1054 1023100044 1110400074 1207400174 1301600234 1324000274 02B0052 04K0301 06F0549 07J0798 09D1055 1023100054 1110400084 1207400184 1301600244 1324000284 02B0053 04K0302 06F0550 07J0799 09D1056 1023600014 1110400094 1208300014 1301600254 1324000304 02B0054 04K0303 06F0551 07J0800 09D1057 1023600024 1110400104 1208300024 1301600264 1324800114 02B0055 04K0304 06G0552 07J0801 09D1058 1023600034 1111500014 1208300034 1301600274 1324800124 02B0056 04K0305 06G0553 07J0802 09D1059 1023600044 1111500024 1208300044 1302400014 1324800134 02C0057 04K0306 06G0554 07J0803 09D1060 1023600054 1111500034 1208300054 1302400024 1324800144 02C0058 04K0307 06G0555 07K0622 09D1061 1023600064 1111500044 1208700014 1302400034 1324800154 02C0059 04K0308 06G0556 07K0623 09D1062 1023600074 1111800124 1208700024 1302400044 1324800164 02C0060 04K0309 06G0557 07K0804 09E1019 1024300094 1111800134 1208700034 1302400054 1324800174 02C0061 04K0310 06G0558 07K0805 09E1069 1024300104 1111800144 1208700044 1302400064 1324800184 02C0062 04L0311 06G0559 07K0806 09E1070 1024300114 1111800154 1208700054 1302400074 1324800194 02C0063 04L0312 06G0560 07K0807 09E1071 1024300154 1111800164 1209400164 1302400084 1324800204 02C0064 04L0313 06G0561 07K0808 09E1079 1024300164 1111800174 1209400174 1303100014 1325400014 02C0065 04L0314 06G0562 07K0809 09E1080 1024300174 1113300064 1209400184 1303100024 1325400024 02D0066 04L0315 06G0563 07K0810 09E1081 1024300184 1113300074 1209400194 1303100034 1325400034 02D0067 04L0316 06G0564 07K0811 09E1082 1024300194 1113300084 1209400204 1303100044 1325400044 02D0068 04L0317 06G0565 07K0812 09E1083 1024300204 1113300094 1210100114 1303100054 1325500014 02D0069 04L0318 06G0566 07K0813 09E1084 1024300214 1113300104 1210100124 1303100064 1325500024 02D0070 04L0319 06G0567 07K0814 09E1085 1024300224 1113300114 1210100134 1303100074 1325500034 02D0071 04L0320 06G0568 07K0815 09E1086 1024300234 1113300124 1210100144 1303100084 1325500044 02E0073 04L0321 06G0569 07K0816 09E1087 1024300244 1113300134 1210100154 1303800094 1325500054 02E0074 04L0322 06H0570 07K0817 09E1088 1025000014 1113300144 1210700014 1303800104 1325500064 02E0075 04L0324 06H0571 07K0818 09G1043 1025000024 1113300154 1210700024 1303800114 1326200074 02E0076 04L0325 06H0572 07K0826 09G1044 1025000034 1113900014 1210700034 1303800124 1326200084 02F0077 05A0326 06H0573 07L0819 09G1046 1025000044 1113900024 1210700044 1303800134 1326200094 02F0078 05A0327 06H0574 07L0820 09G1063 1025000054 1113900034 1210700054 1303800144 1326200104 02F0079 05A0328 06H0575 07L0822 09G1064 1025000064 1113900044 1210900264 1304500084 1326200114 02F0080 05A0329 06H0576 07L0823 09G1078 1025000074 1113900054 1210900274 1304500094 1326200124 02F0081 05A0330 06H0577 07L0824 09H1065 1025000084 1113900064 1210900284 1304500104 1326700174 02F0082 05A0331 06H0578 07L0825 09H1066 1025000094 1113900074 1210900294 1304900014 1326700204 02F0083 05A0332 06H0579 07L0827 09H1067 1025000104 1113900084 1210900304 1304900024 1326700234 02F0084 05A0333 06H0580 07L0828 09H1068 1025900014 1113900094 1211800064 1304900034 1326700244 02F0085 05A0334 06H0581 07L0829 09H1072 1025900024 1113900104 1211800074 1304900044 1327500014 02F0086 05A0335 06H0582 07L0830 09H1073 1025900034 1115300614 1211800084 1304900054 1327500024 02F0087 05A0341 06H0583 07L0831 09H1074 1025900044 1115300624 1211800094 1304900064 1327500034 02F0088 05A0342 06H0584 07L0832 09H1075 1025900054 1115300634 1212900014 1305200014 1327500044 02G0089 05A0343 06H0585 07L0833 09H1076 1025900064 1115300644 1213100114 1305200024 1327500054 02G0090 05B0344 06I0586 07L0834 09H1077 1025900074 1115300654 1213100124 1305200034 1327500064 02G0091 05D0336 06I0587 07L0835 09H1089 1025900084 1115300664 1213100134 1305200044 1327500074 02G0092 05D0337 06I0588 07L0836 09H1090 1025900094 1115300674 1213100144 1305200054 1327500084 02G0093 05D0338 06I0589 07L0837 09I1091 1025900104 1115300684 1213100154 1305200064 1327500094 02G0094 05D0339 06I0590 08A0838 09I1092 1027000074 1115300694 1213800114 1305200074 1327500104 02G0095 05D0340 06I0591 08A0839 09I1093 1027000084 1115300704 1213800124 1305200084 1328200014 02G0096 05D0345 06I0592 08A0840 09I1094 1027000094 1115900504 1213800134 1305800214 1328200024 02G0097 05D0346 06I0593 08A0841 09I1095 1027200114 1115900514 1213800144 1305800224 1328200034 02G0098 05D0347 06I0594 08A0842 09I1096 1027200124 1115900524 1213800154 1305800234 1328200044 02H0099 05E0348 06I0595 08A0843 09I1097 1027200134 1115900534 1215000204 1305800244 1328200054 02H0100 05E0349 06I0596 08A0844 09I1098 1027200144 1115900544 1215000214 1305800254 1328200064 02H0101 05E0350 06I0597 08A0845 09I1099 1027200154 1115900554 1215000224 1305800264 1328200074 02H0102 05E0351 06I0598 08A0847 09I1100 1027200164 1115900564 1215000234 1305800274 1328200084 02H0103 05E0352 06I0599 08A0848 09I1101 1027200174 1115900574 1215000244 1305800284 1329600134 02H0104 05E0353 06I0600 08A0849 09I1102 1027400014 1115900584 1215800014 1306500064 1329600144 02I0105 05E0378 06I0601 08A0850 09I1104 1027400024 1115900594 1215800024 1306500074 1329600154 02I0106 05E0379 06I0602 08A0851 09I1105 1027400034 1117500554 1215800034 1306600214 1329600164 02I0107 05F0354 06I0603 08B0852 09I1106 1027400044 1118100014 1215800044 1306600224 1329600174 02I0108 05F0355 06J0604 08B0853 09I1114 1027400054 1118100024 1215800054 1306600234 1329600184 02I0109 05F0356 06J0605 08B0854 09I1115 1027400064 1118600014 1215800064 1306600244 1329800134 02I0110 05F0357 06J0606 08B0855 09J1103 1027400074 1118600024 1215800074 1307000114 1329800144 02K0111 05F0358 06J0607 08B0856 09J1116 1027400084 1118600034 1215800084 1307000124 1329800154 02K0112 05F0359 06J0608 08B0857 09J1117 1027400094 1118600044 1215800094 1307000134 1329800164 02K0115 05F0360 06J0609 08B0858 09J1118 1027400104 1118800174 1215800104 1307000144 1330300314 02K0116 05F0361 06J0610 08B0859 09J1119 1028500194 1118800184 1216500114 1307000154 1330300324 02K0117 05F0362 06J0611 08B0860 09J1120 1028500204 1118800194 1216500124 1307000164 1330300334 02K0118 05F0363 06J0612 08B0861 09J1121 1028500214 1118800204 1216500134 1307300094 1330300344 02L0113 05F0364 06J0613 08B0862 09J1122 1028500224 1119400104 1216500144 1307300104 1330300354 02L0114 05F0365 06J0614 08B0863 09J1123 1028500234 1119400114 1216500154 1307700014 1330300364 02L0119 05F0366 06J0615 08B0864 09J1124 1029200014 1119400124 1218000294 1307700024 1331000424 02L0120 05F0367 06K0617 08C0865 09J1125 1029200024 1119400134 1218000304 1307800034 1331000434 03A0121 05F0369 06K0618 08C0866 09J1126 1029200034 1119400144 1218000314 1307800044 1331000444 03A0122 05F0371 06K0619 08C0867 09J1127 1029200044 1119400154 1218000324 1308600074 1331000454 03A0123 05F0380 06K0620 08C0869 09L1107 1029200054 1119400164 1218000334 1308600084 1331000464 03A0124 05F0381 06K0621 08C0870 09L1108 1029200064 1119400174 1218700064 1308600094 1331000474 03A0133 05G0370 06L0625 08C0871 09L1109 1029200074 1119400184 1218700074 1308600104 1331000484 03B0127 05G0372 06L0626 08C0872 09L1110 1029200084 1120200114 1218700084 1308800014 1331000494 03B0128 05G0373 06L0627 08C0873 09L1111 1029200094 1120200124 1218700094 1308800024 1331700174 03B0129 05G0374 06L0628 08C0874 09L1112 1029200104 1120200134 1218700104 1309100074 1331700184 03B0130 05G0375 06L0629 08C0875 09L1113 1030200134 1120200144 1219300154 1309100084 1331700194 03B0140 05G0376 06L0630 08C0876 09L1129 1030200144 1120200154 1219300164 1309100094 1331700204 03C0125 05G0377 06L0631 08C0878 09L1130 1030200154 1120200164 1219300174 1309100104 1331700214 03C0126 05G0389 06L0632 08C0879 09L1131 1030200164 1120200174 1219300184 1309300014 1331700224 03C0136 05G0390 06L0633 08C0880 09L1132 1030200174 1120200184 1219300194 1309300024 1331700234 03C0138 05G0391 06L0634 08C0881 09L1133 1030200424 1120200194 1220500264 1309300254 1331700244 03C0139 05G0392 06L0635 08C0882 09L1134 1030200434 1120200204 1220500274 1309300264 1333100294 03D0134 05G0393 06L0636 08D0877 09L1135 1030200444 1121400074 1220500284 1309300274 1333100304 03D0156 05G0394 06L0637 08D0883 09L1136 1030200454 1121400084 1220500294 1309300284 1333100314 03D0157 05G0395 06L0638 08D0884 09L1137 1030200464 1121400094 1220500304 1309800134 1333100324 03D0158 05G0396 06L0639 08D0885 09L1138 1030800014 1121400104 1220500314 1309800144 1333100334 03E0159 05H0382 06L0640 08D0886 09L1139 1030800024 1121400114 1220500324 1309800154 1333100344 03E0160 05H0383 06L0641 08D0887 09L1140 1030800034 1121400124 1220500334 1309800164 1333100354 03E0161 05H0384 06L0642 08D0888 09L1141 1030800044 1124200024 1220500344 1309800174 1333100364 03F0131 05H0385 07A0643 08D0889 09L1142 1030800054 1124200034 1220500354 1309800184 1333700114 03F0132 05H0386 07A0644 08D0890 09L1143 1030800064 1124200044 1221400014 1309800214 1333700124 03F0137 05H0387 07A0645 08D0891 09L1144 1030800074 1124200054 1221400024 1310100314 1333700134 03F0141 05H0388 07A0646 08D0892 09L1145 1030800084 1124200064 1221400034 1310100324 1333700144 03F0142 05H0397 07A0647 08D0893 09L1146 1030800094 1125000054 1221400044 1310100334 1333700154 03F0143 05H0398 07B0648 08E0895 09L1147 1030800104 1125000064 1221400054 1310200084 1333700164 03G0144 05H0402 07B0649 08E0896 09L1152 1033300014 1125000074 1222200014 1310200094 1333700174 03G0145 05H0403 07B0650 08E0897 09L1153 1033300024 1125000084 1222200024 1310200104 1333700184 03G0146 05H0404 07B0651 08E0898 09L1154 1033300034 1127900114 1222200034 1310200114 1334400154 03G0147 05H0405 07B0652 08E0899 09L1155 1033300044 1127900124 1222200044 1310200124 1334400164 03G0148 05H0406 07B0653 08E0900 10B1157 1033500014 1127900134 1222200054 1310200134 1334400174 03G0149 05I0399 07B0654 08E0901 10B1158 1033500024 1127900144 1222200064 1310500094 1334400184 03G0150 05I0400 07B0655 08E0902 10B1159 1033500034 1127900154 1222200074 1310500104 1334400194 03G0151 05I0401 07B0656 08E0903 10B1160 1033500044 1127900164 1222200084 1310700584 1334400204 03G0152 05I0407 07B0657 08E0904 10B1161 1033500054 1127900174 1222200094 1310700594 1334400214 03G0162 05I0408 07B0658 08E0905 10B1162 1033500064 1127900184 1222200104 1310700604 1334400224 03G0163 05I0409 07B0659 08E0906 10B1163 1033500074 1127900194 1222800014 1310700614 1334400234 03H0135 05I0410 07B0660 08E0907 10B1164 1033500084 1127900204 1222800024 1310700624 1334400244 03H0164 05I0411 07B0661 08E0908 10B1165 1033500094 1130500054 1222800034 1310700634 1334400254 03H0165 05I0412 07B0662 08E0909 10B1166 1033500104 1130500064 1222800044 1310700644 1334400264 03I0153 05I0413 07C0663 08F0910 10B1167 1033700214 1130500074 1222800124 1310700654 1334400274 03I0166 05I0414 07C0664 08F0911 10B1168 1033700224 1130500084 1222800134 1310700664 1334400284 03I0167 05I0415 07C0665 08F0912 10B1169 1033700234 1130800374 1223400734 1310700674 1335400114 03I0168 05J0416 07C0666 08F0913 10B1170 1033700244 1130800384 1223400744 1312000114 1335400124 03I0169 05J0417 07C0667 08F0914 10B1171 1033700254 1130800394 1223400754 1312000124 1335400134 03I0170 05J0418 07C0668 08F0915 10B1172 1033700264 1130800404 1223400764 1312000134 1335400144 03I0171 05J0419 07C0669 08F0916 10B1173 1033700274 1130800414 1223400774 1312000144 1400600014 03I0172 05J0420 07C0670 08F0917 10B1174 1033700284 1130800424 1223400784 1312000154 1400600024 03I0173 05J0421 07C0671 08F0918 X7L0821 1033700294 1131300134 1223400794 1312000164 1400600034 03J0174 05J0422 07C0672 08F0919 1009800014 1033700304 1131300144 1223400804 1312000174 1400600044 03J0175 05J0423 07C0673 08F0920 1009800024 1034100534 1131300154 1223400814 1312000184 1400800084 03J0176 05J0424 07C0674 08F0921 1009800034 1034100544 1131300164 1223400824 1312000194 1400800094 03J0177 05J0425 07C0675 08F0922 1009800044 1034100554 1131300174 1223400834 1312000204 1400800104 03J0178 05J0426 07C0676 08F0923 1009800054 1034700014 1131300184 1223400844 1312900014 1400800114 03K0179 05J0427 07C0677 08F0924 1009800064 1034700024 1131300194 1223400854 1312900024 1400800124 03K0180 05J0428 07C0678 08F0925 1009800074 1034700034 1131300204 1223400864 1312900034 1400800134 03K0181 05K0429 07D0679 08F0926 1009800084 1034700044 1131300214 1223400874 1312900044 1400800144 03K0182 05K0430 07D0680 08F0927 1009800094 1035800014 1131300224 1223400884 1312900054 1400800154 03K0183 05K0431 07D0681 08F0928 1009800104 1035800024 1131300234 1225100014 1313600454 1400800164 03K0184 05K0432 07D0682 08F0929 1009800114 1035800034 1131300244 1225100024 1313600464 1401500684 03K0185 05K0433 07D0683 08F0930 1009800124 1035800044 1131900014 1225100034 1313600474 1401500714 03K0186 05K0434 07D0684 08G0931 1009800134 1035800054 1131900024 1225100044 1313600484 1402300014 03K0187 05K0435 07D0685 08G0932 1009800144 1035800064 1131900034 1225100054 1313600494 1402300024 03L0188 05K0436 07D0686 08G0933 1009800154 1035800074 1131900044 1225100064 1313600504 1402400834 03L0189 05K0437 07D0687 08G0934 1009800164 1035800084 1131900054 1225100074 1314300084 1402400844 03L0190 05K0438 07D0688 08G0935 1010400014 1035800094 1131900064 1225100084 1314300094 1402400854 03L0191 05L0439 07D0689 08G0936 1010400024 1035800104 1131900074 1225100094 1314300104 1402400864 03L0192 05L0440 07D0690 08G0937 1010400034 1101200154 1131900084 1225100104 1314300114 1402400874 03L0193 05L0441 07D0691 08G0938 1010400044 1101200164 1131900094 1225100114 1314300124 1402400884 03L0195 05L0442 07D0692 08G0939 1010400054 1101200174 1131900104 1225500084 1314300134 1402400894 03L0196 05L0443 07D0693 08G0940 1010400064 1101200184 1131900114 1225500094 1314300144 1403600094 03L0197 05L0444 07D0694 08G0941 1010400074 1101200194 1131900124 1225500104 1314900014 1403600104 04A0198 05L0445 07D0695 08G0942 1010400084 1101200204 1132800114 1225500114 1314900024 1403800014 04A0201 05L0446 07E0624 08G0943 1010400094 1101200214 1132800124 1225500124 1314900034 1403800024 04A0202 05L0447 07E0696 08G0944 1011000014 1101200224 1132800134 1226300044 1314900044 1404300444 04A0203 05L0448 07E0697 08G0945 1011000024 1101200234 1132800144 1226300054 1314900054 1404300454 04A0204 06A0449 07E0698 08H0946 1011000034 1101200244 1132800154 1226300064 1314900064 1404300464 04A0205 06A0450 07E0699 08H0947 1011000044 1101700014 1132800164 1226800234 1314900074 1404500134 04A0206 06A0451 07E0700 08H0948 1011000054 1101700024 1132800174 1226800244 1315600374 1404500144 04A0207 06A0452 07E0701 08H0949 1011000064 1101700034 1132800184 1226800254 1315600384 1404500154 04A0208 06A0453 07E0702 08H0950 1011000074 1101700044 1132800194 1226800264 1315600394 1404500164 04A0209 06A0454 07E0703 08H0951 1011000084 1101700054 1132800204 1226800274 1315600404 1404500174 04A0210 06A0455 07E0704 08H0952 1011000094 1101700064 1133400114 1226800284 1315600414 1405100024 04B0194 06A0456 07E0705 08H0953 1011000104 1101700074 1133400124 1226800294 1315600424 1405200254 04B0199 06A0457 07E0706 08H0954 1011000114 1101700084 1133400134 1226800304 1315600434 1405200284 04B0211 06A0458 07E0707 08H0955 1011000124 1101700094 1133400144 1226800314 1316400284 1405600014 04B0212 06A0459 07E0708 08H0956 1011000134 1101700104 1133400154 1226800324 1316400294 1405600054 04B0213 06A0460 07E0709 08H0957 1011000144 1103100014 1133900014 1227700224 1316400304 1405600064 04B0214 06A0461 07E0710 08H0958 1011000154 1103100024 1133900024 1227700234 1316400314 1405900214 04B0215 06A0462 07E0711 08H0959 1013900014 1103100034 1133900034 1227700244 1316400324 1405900224 04B0216 06A0463 07E0712 08H0960 1013900024 1103100044 1133900044 1227700254 1316400334 1405900234 04C0200 06A0464 07E0713 08I0963 1015400014 1103100054 1133900054 1227700264 1316400344 1405900244 04C0217 06A0465 07E0714 08I0964 1015400024 1103300014 1134000114 1227700274 1317200014 1405900254 04C0218 06A0466 07E0715 08I0965 1015400034 1103300024 1134000124 1227700284 1317200024 1405900264 04C0219 06B0467 07F0716 08I0966 1015400044 1103300034 1134000134 1227700294 1317200034 1405900274 04C0220 06B0468 07F0717 08I0967 1015400054 1103300044 1134000144 1228500194 1317200044 1405900284 04C0221 06B0469 07F0718 08I0968 1015400064 1103300054 1134000154 1228500204 1317200054 1405900294 04C0222 06B0470 07F0719 08I0969 1015400074 1104000054 1134000164 1228500214 1317200064 1405900304 04C0223 06B0471 07F0720 08I0970 1015400084 1104000064 1134000174 1228500224 1317200074 1408700054 04C0224 06B0472 07F0721 08I0971 1016100314 1104000074 1134000184 1228500234 1317500054 1408700064 04D0225 06B0473 07F0722 08I0972 1016100324 1104000084 1134000194 1228500244 1317500064 1409000464 04D0226 06B0474 07F0723 08I0973 1016100334 1104000094 1134000204 1229100154 1317800094 1409000474 04D0227 06B0475 07F0724 08I0974 1016100344 1104000104 1200500114 1229100164 1317800104 1409300074 04D0228 06B0476 07F0725 08I0975 1016500014 1104000114 1200500124 1229100174 1318200034 1409300084 04D0229 06B0477 07F0726 08I0977 1016500024 1104000124 1200500134 1229100184 1318200044 1409300094 04D0230 06B0478 07F0727 08I0978 1016500034 1104000134 1200500144 1229100194 1318200054 1409300104 04D0231 06B0479 07F0728 08I0979 1016500044 1104000144 1200500154 1229100204 1318300314 1409300114 04D0232 06B0480 07F0729 08I0980 1016500054 1104700014 1200500164 1229100214 1318300324 1409300124 04D0235 06B0481 07F0730 08I0981 1017200114 1104700024 1200500174 1229900014 1318300334 1409800134 04D0236 06B0482 07F0731 08I0982 1017200124 1104700034 1200500184 1229900024 1318300344 1409800144 04D0237 06B0483 07F0732 08I0983 1017200134 1104700044 1200500194 1229900034 1318300354 1409800154 04E0233 06C0484 07G0733 08I0984 1017200144 1104700054 1200500204 1229900044 1318300364 1409800164 04E0234 06C0485 07G0734 08I0985 1017200154 1104700064 1201300754 1229900054 1318600014 1409800174 04F0238 06C0486 07G0735 08J0986 1017200164 1104700074 1201300764 1229900064 1318600024 1409800184 04F0239 06C0487 07G0736 08J0987 1017200174 1104700084 1201300774 1229900074 1318900014 1410500134 04F0240 06C0488 07G0737 08J0988 1017900014 1104700094 1201300784 1229900084 1318900024 1410500144 04F0241 06C0489 07G0738 08J0989 1017900024 1104700104 1201300794 1230500154 1318900034 1411201534 04F0242 06C0490 07G0739 08J0990 1017900034 1105200064 1201700324 1230500164 1318900044 1411201544 04F0243 06C0491 07G0740 08J0991 1018000364 1105400014 1201700334 1230500174 1318900054 1411201554 04F0244 06C0492 07G0741 08J0992 1018000374 1105400024 1201700344 1230500184 1319300154 1411201564 04F0245 06C0493 07G0742 08J0993 1018000384 1105400034 1201700354 1230600074 1319300164 1411201574 04F0246 06C0494 07G0743 08J0994 1018000394 1105400044 1201700364 1230600084 1319700014 1411201584 04F0247 06C0495 07G0744 08J0995 1018200014 1106200014 1202400154 1230600094 1320000014 1411800174 04F0248 06C0496 07G0745 08K0996 1018200024 1106200024 1202400164 1230600104 1320000024 1411800234 04G0249 06C0497 07G0746 08L0998 1018200034 1106200034 1202400174 1230600114 1320000034 1411800244 04G0250 06C0498 07G0747 08L0999 1018200044 1106200044 1202400184 1230600124 1320000044 & 1414600124.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactMrs. Kelly J. Davis
269-389-2921
Manufacturer Reason
for Recall
The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
FDA Determined
Cause 2
Labeling design
ActionThe firm sent Medical Device Upgrade Notification letters dated July 11, 2014 to their customers.
Quantity in Commerce2,460 units
DistributionNationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI & WV.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LFL
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