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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmSeptember 23, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on January 21, 2004
Recall NumberZ-0044-04
Recall Event ID 27301
ProductPin Driver Coupler, 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***
Code Information Serial numbers: 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1016, 1021, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1030, 1031, 1032, 1034, 1035, 1036, 1038, 1039, 1040, 1041, 1042, 1043, 1046, 1047, 1048, 1049, 1051, 1052, 1053, 1054, 1057, 1058, 1059, 1060, 1061, 1062, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1093, 1095, 1096, 1097, 1098, 1099, 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1113, 1114, 1115, 1116, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1149, 1150, 1151, 1152, 1153, 1155, 1156, 1157, 1158.
FEI Number 2020601
Recalling Firm/
Manufacturer		 Microaire Surgical Instruments
1641 Edlich Dr
Charlottesville VA 22911
For Additional Information ContactChris Spofford
800-538-5561 Ext. 344
Manufacturer Reason
for Recall		Wiring pin locking mechanism defective, potential to come apart in surgical site.
FDA Determined
Cause 2		Other
ActionThe 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.
Quantity in Commerce129
DistributionProduct was distributed to direct accounts around the United States and to distributors around the world.
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.
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