Product Description
Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part ***MicroAire Surgical Instruments, 1641 Edlich Drive, Charlottesville, VA 22911***.
Reason for Recall
Wiring pin locking mechanism defective, potential to come apart in surgical site.
Action Details
The firm notified consignees by certified letter 9/23/03. The recall notifications were serial number specific and advised consignees of the potential defect with the wirning pin/locking mechanism. Consignees were instructed to cease use and distribution and obtain a return authorization for repair. Distributors were requested to extend the recall and recover and return devices for repair.
Distribution Pattern
Product was distributed to direct accounts around the United States and to distributors around the world.
Code Information / Serial Numbers
Serial numbers: 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1021, 1022, 1024, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032, 1033, 1034, 1035, 1036, 1037, 1038, 1039, 1042, 1043, 1044, 1045, 1047, 1049, 1050, 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1064, 1065, 1066, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1079, 1082, 1083, 1084, 1087, 1088, 1089, 1090, 1094, 1095, 1096, 1097, 1099, 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1112, 1113, 1114, 1115, 1117, 1118, 1119, 1120, 1121, 1122, 1124, 1126, 1127, 1128, 1129, 1130, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1162, 1163, 1164, 1165, 1166, 1167, 1168, 1169, 1170, 1171, 1172, 1173, 1175, 1176, 1177, 1178, 1179.