Class 2 Device Recall microTargeting Drive

• Date Initiated by Firm: March 30, 2010
• Date Posted: November 03, 2010
• Recall Status: Terminated on February 25, 2015
• Recall Number: Z-0313-2011
• Recall Event ID: 55287
• 510(K)Number: K003776
• Product Classification: neurological stereotaxic instrument - Product Code HAW
• Product: microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
• Code Information: Not serialized. Manufactured after January 21, 2010 and prior to March 22, 2010.
• Recalling Firm/ Manufacturer: FHC, Inc.; 1201 Main Street; Bowdoinham ME 04008
• For Additional Information Contact: Keri S. Seitz; 207-666-5651 Ext. 2210
• Manufacturer Reason for Recall: Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
• FDA Determined Cause: Device Design
• Action: FHC issued an "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 29, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. FHC informed the customers that that they had returned to the original design of the fixation screw in the Depth Stop Adapter. FHC sent replacement Depth Stop Adapter with an original fixation screw. The customers were instructed to discard the recalled Depth Stop Adapter (s) and replace with the enclosed corrected version(s) and sign and fax the receipt notification to 207-666-8309 as proof of their receipt of notification. For assistance with the product replacement, contact the FHC's technical support line at 800-326-2905. This line is staffed 24 hours a day. Should you have any further questions regarding this matter, please contact Dorothee Sasse, product manager, or Keri Seitz, recall coordinator at 207-666-8190.
• Quantity in Commerce: 1
• Distribution: Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
• 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