Precision Implantable Pulse Generator (IPG), Model Number SC-110
FDA device recall Z-0055-2008 · posted 2007-10-12 · Terminated
Recall details
- Recalling firm
- Advanced Bionics Corp
- Reason for recall
- Mislabeled: Product labeled with the incorrect shelf-life information.
- Action taken
- There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LGW
- Quantity affected
- 1 unit affected
- Distribution
- MD
- Date initiated
- 2007-08-03
- Date posted
- 2007-10-12
- Date terminated
- 2012-01-25
- Location
- Sylmar, CA
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