FDA Medical Device Recalls (openFDA)
Microaire Surgical Instruments: 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***.
- Recall number
- Z-0043-04
- Recalling firm
- Microaire Surgical Instruments
- 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***.
- Status
- Terminated
- Initiated
- 2003-09-23
- Posted
- 2003-10-15
- Terminated
- 2004-01-21
- Reason
- Wiring pin locking mechanism defective, potential to come apart in surgical site.
- 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
- 135
- Distribution
- Product was distributed to direct accounts around the United States and to distributors around the world.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 2020601
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28