Z-0055-2008

Precision Implantable Pulse Generator (IPG), Model Number SC-110

Name: Z-0055-2008 Precision Implantable Pulse Generator (IPG), Model Number SC-110
Creator: Advanced Bionics Corp
Published: 2007-08-03
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2007-08-03 / Terminated / root cause: labeling and UDI

FDA source

Advanced Bionics Corp began a recall of Precision Implantable Pulse Generator (IPG), Model Number SC-110 on 2007-08-03. The reason FDA records is "Mislabeled: Product labeled with the incorrect shelf-life information". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0055-2008
Status: Terminated
Initiated: 2007-08-03
Posted: 2007-10-12
Terminated: 2012-01-25
Recalling firm: Advanced Bionics LLC
Product: Precision Implantable Pulse Generator (IPG), Model Number SC-110
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Mislabeled: Product labeled with the incorrect shelf-life information.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1 unit affected
Distribution: MD
Product codes and lots: Model Number SC-1110, Serial Number 161767

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)