Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342
Lot Codes / Batch Numbers
Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943
Products Sold
Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943
Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342 is recalling Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Mode due to A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026