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STar Drive System recallZ-0312-2011 · FHC, Inc. · initiated Mar 30, 2010

Terminated All recalls posted in November 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from FHC, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0312-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 30, 2010
Posted by the FDA
Nov 3, 2010
Recalling firm
FHC, Inc.
Quantity
7
Product code
HAW
FDA submissions
K092562
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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

9 devices cleared under K092562 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 55287).

Sources and updates

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