Device Recall STar Drive System

Serial Numbers:  20640, 21292, 21182, 21276, 21267, 21183, 20605 Manufactured after January 21, 2010 and prior to March 22, 2010.

Neurological Devices

2

No

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.

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.