microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) 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.
This recall has been terminated (originally issued November 3, 2010).
- Company
- Fhc, Inc.
- Recall Initiated
- March 30, 2010
- Posted
- November 3, 2010
- Terminated
- February 25, 2015
- Recall Number
- Z-0311-2011
- Quantity
- 18 units
- Firm Location
- Bowdoinham, ME
- Official Source
- View on FDA website ↗
Reason for Recall
Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.
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.
Lot / Code Info
Serial Numbers: 14511,16997, 15104 Medtronic: 15140,15108, 15084, 15081, 21380, 21375, 15153, 15107, 15118, 15098, 15092, 15071, 21372, 21389, 21386 Manufactured after January 21, 2010 and prior to March 22, 2010.
Root Cause
Device Design
Action Taken
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.