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***.
| Date | Oct 15, 2003 (initiated Sep 23, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.