Z-0043-04

Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are...

Name: Z-0043-04 Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are...
Creator: Microaire Surgical Instruments
Published: 2003-09-23
License: https://open.fda.gov/license/

MicroAire Surgical Instruments, LLC / initiated 2003-09-23 / Terminated

FDA source

Microaire Surgical Instruments began a recall of Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one... on 2003-09-23. The reason FDA records is "Wiring pin locking mechanism defective, potential to come apart in surgical site". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0043-04
Status: Terminated
Initiated: 2003-09-23
Posted: 2003-10-15
Terminated: 2004-01-21
Recalling firm: MicroAire Surgical Instruments, LLC
Product: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 135
Distribution: Product was distributed to direct accounts around the United States and to distributors around the world.
Product codes and lots: 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.

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)