Recall Z-0312-2011
FHC, Inc. · initiated March 30, 2010
Product
STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME 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.
Codes / lots: Serial Numbers: 20640, 21292, 21182, 21276, 21267, 21183, 20605 Manufactured after January 21, 2010 and prior to March 22, 2010.
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 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.
Details
- Recall number
- Z-0312-2011
- Initiated
- March 30, 2010
- Posted by FDA
- November 3, 2010
- Terminated
- February 25, 2015
- Product code
- HAW – Neurological Stereotaxic Instrument
- Quantity
- 7
- 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.
- Recalling firm
- FHC, Inc., Bowdoinham, ME
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0311-2011 | microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01…Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 03/30/2010Terminated |
| Z-0313-2011 | microTargeting Drive DBS Lead Holder 66-CN-DB Product is the FHC DBS Depth Stop Adapter…Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 03/30/2010Terminated |
| Z-0314-2011 | Depth Stop Adapter 66-AC-DS(1.8), E6-01-.5 used with the microTargeting and STar Drives…Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 03/30/2010Terminated |