Class 2 Device Recall Precision Implantable Pulse Generator

• Date Initiated by Firm: August 03, 2007
• Date Posted: October 12, 2007
• Recall Status: Terminated 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/ Manufacturer: Advanced Bionics Corp; 12740 San Fernando Rd; Sylmar CA 91342-3728
• For Additional Information Contact: Kaoru Lee Adair; 818-362-1669
• Manufacturer Reason for Recall: Mislabeled: Product labeled with the incorrect shelf-life information.
• FDA Determined Cause: 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