Devices

Device Recall STar Drive System

Model / Serial
Serial Numbers: 20640, 21292, 21182, 21276, 21267, 21183, 20605 Manufactured after January 21, 2010 and prior to March 22, 2010.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
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.
Product Description
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.
Manufacturer
FHC, Inc.
1 Event
- Recall of Device Recall STar Drive System

Manufacturer

FHC, Inc.

Manufacturer Address
FHC, Inc., 1201 Main Street, Bowdoinham ME 04008
Manufacturer Parent Company (2017)
Fhc Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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