Events

Recall of Device Recall STar Drive System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by FHC, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55287
  • Event Risk Class
    Class 2
  • Event Number
    Z-0312-2011
  • Event Initiated Date
    2010-03-30
  • Event Date Posted
    2010-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90479
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    neurological stereotaxic instrument - Product Code HAW
  • Reason
    Fixation thumbscrew on the dbs depth stop adapter may be overtightened and damage the implantable lead.
  • 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.

Device

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.

Manufacturer

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