Z-0396-05

Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System

Name: Z-0396-05 Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
Creator: Advanced Bionics Corporation
Published: 2004-11-11
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2004-11-11 / Terminated

FDA source

Advanced Bionics Corporation began a recall of Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System on 2004-11-11. The reason FDA records is "A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0396-05
Status: Terminated
Initiated: 2004-11-11
Posted: 2005-01-15
Terminated: 2005-03-08
Recalling firm: Advanced Bionics LLC
Product: Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
FDA root cause: Other
Action: Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice.
Quantity in commerce: 237 patients are implanted.
Distribution: Nationwide
Product codes and lots: All Codes

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)