Z-0299-2007

Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers...

Name: Z-0299-2007 Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers...
Creator: Advanced Bionics Corporation
Published: 2006-09-21
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2006-09-21 / Terminated

FDA source

Advanced Bionics Corporation began a recall of Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70 on 2006-09-21. The reason FDA records is "A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0299-2007
Status: Terminated
Initiated: 2006-09-21
Posted: 2007-01-10
Terminated: 2012-01-25
Recalling firm: Advanced Bionics LLC
Product: Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
FDA root cause: Other
Action: In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006. The recall notification letters will instruct physicians to immediately return the unimplanted units.
Quantity in commerce: 18
Distribution: Worldwide.
Product codes and lots: Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943

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)