Pin Driver Coupler, component of MicroAire Drill\Reamer Model 7500. Driver couplers are reuseable medical devices, non-s
FDA device recall Z-0044-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Microaire Surgical Instruments
- Reason for recall
- Wiring pin locking mechanism defective, potential to come apart in surgical site.
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- 129
- Distribution
- Product was distributed to direct accounts around the United States and to distributors around the world.
- Date initiated
- 2003-09-23
- Date posted
- 2003-10-15
- Date terminated
- 2004-01-21
- Location
- Charlottesville, VA
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