FDA Medical Device Recalls (openFDA)
Advanced Bionics Corp: Precision Implantable Pulse Generator (IPG), Model Number SC-110
- Recall number
- Z-0055-2008
- Recalling firm
- Advanced Bionics Corp
- Product
- Precision Implantable Pulse Generator (IPG), Model Number SC-110
- Status
- Terminated
- Initiated
- 2007-08-03
- Posted
- 2007-10-12
- Terminated
- 2012-01-25
- Reason
- Mislabeled: Product labeled with the incorrect shelf-life information.
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 1 unit affected
- Distribution
- MD
- Lot, serial or model codes
- Model Number SC-1110, Serial Number 161767
- 510(k) numbers
- not on file
- PMA numbers
- ["P030017"]
- Product code
- LGW
- Firm FEI
- 1000220815
- Firm city
- Sylmar
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28