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U.S. Department of Health and Human Services

Class 2 Device Recall microTargeting Drive

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  Class 2 Device Recall microTargeting Drive see related information
Date Initiated by Firm March 30, 2010
Date Posted November 03, 2010
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = FHC, INC.
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