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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Bionics Precision Linear Leads

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  Class 2 Device Recall Advanced Bionics Precision Linear Leads see related information
Date Initiated by Firm September 21, 2006
Date Posted January 10, 2007
Recall Status1 Terminated 3 on January 25, 2012
Recall Number Z-0299-2007
Recall Event ID 36624
PMA Number P030017 
Product Classification spinal cord stimulation leads - Product Code LGW
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.
Code Information Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943
Recalling Firm/
Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342
For Additional Information Contact Kaoru Lee Adair
Manufacturer 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 Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LGW and Original Applicant = Boston Scientific Corp.