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***
FDA Recall Z-0044-04 · Posted 2003-10-15
Recalling FirmMicroaire Surgical Instruments
Recall StatusTerminated
Date Initiated2003-09-23
Date Terminated2004-01-21
Product Quantity129
Reason for Recall
Wiring pin locking mechanism defective, potential to come apart in surgical site.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to direct accounts around the United States and to distributors around the world.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.