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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Implantable Pulse Generator

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  Class 2 Device Recall Precision Implantable Pulse Generator see related information
Date Initiated by Firm August 03, 2007
Date Posted October 12, 2007
Recall Status1 Terminated 3 on January 25, 2012
Recall Number Z-0055-2008
Recall Event ID 39383
PMA Number P030017 
Product Classification Implantable Pulse Generator - Product Code LGW
Product Precision Implantable Pulse Generator (IPG), Model Number SC-110
Code Information Model Number SC-1110, Serial Number 161767
Recalling Firm/
Advanced Bionics Corp
12740 San Fernando Rd
Sylmar CA 91342-3728
For Additional Information Contact Kaoru Lee Adair
Manufacturer Reason
for Recall
Mislabeled: Product labeled with the incorrect shelf-life information.
FDA Determined
Cause 2
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
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.