Known Identifiers & Locations
FEI Numbers
2020601
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0043-04 |
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: Wiring pin locking mechanism defective, potential to come apart in surgical site.
|
2003-09-23 |
Terminated
|
View Details
|
| Z-0044-04 |
Pin 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***
Reason: Wiring pin locking mechanism defective, potential to come apart in surgical site.
|
2003-09-23 |
Terminated
|
View Details
|
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