Class 2 Device Recall FHC Microtargeting Drive System

• Date Initiated by Firm: October 08, 2008
• Date Posted: December 22, 2008
• Recall Status: Terminated on May 02, 2012
• Recall Number: Z-0486-2009
• Recall Event ID: 50086
• 510(K)Number: K011992
• Product Classification: Stereotaxic Instrument - Product Code HAW
• Product: FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.
• Code Information: Not coded.
• FEI Number: 3002250546
• Recalling Firm/ Manufacturer: FHC, Inc.; 1201 Main Street; Bowdoinham ME 04008
• For Additional Information Contact: SAME; 207-666-8190
• Manufacturer Reason for Recall: Measuring fixture is incorrectly graduated.
• FDA Determined Cause: Process control
• Action: FHC provided letter notification to FHC Field Representatives on 10/08/08 to hand deliver to customers. FHC Field Representatives will remove incorrectly marked product and provide replacement product. Direct questions to an FHC representative or FHC Quality and Regulatory Affairs at 207-666-5651, ext. 2210.
• Quantity in Commerce: 5 units
• Distribution: Nationwide Distribution including states of CO, FL, NC and NM.
• 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.

• 510(K) Database: 510(K)s with Product Code = HAW