Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyb
FDA device recall Z-0171-2008 · posted 2007-11-28 · Terminated
Recall details
- Recalling firm
- Cyberonics, Inc
- Reason for recall
- Dissolution/Fractures to the leads of the VNS Therapy System
- Action taken
- Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LYJ
- Quantity affected
- 21,419 units.
- Distribution
- Worldwide Distribution - USA and countries of Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ind
- Date initiated
- 2007-08-02
- Date posted
- 2007-11-28
- Date terminated
- 2009-10-05
- Location
- Houston, TX
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