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U.S. Department of Health and Human Services

Class 2 Device Recall component of NeuroPort Array brain monitoring device.

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 Class 2 Recall
component of NeuroPort Array brain monitoring device.
see related information
Date Posted May 20, 2010
Recall Status1 Terminated on May 25, 2010
Recall Number Z-1619-2010
Recall Event ID 55304
Premarket Notification
510(K) Number
K042384 
Product Classification Amplifier, Physiological Signal - Product Code GWL
Product Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT. Intended use: The Inserter Wand Holder serves two key functions. It firmly secures the Inserter Wand to prevent recoil during the NeuroPort Array insertion process, and it facilitates precision alignment of the Inserter Wand with respect to the back of the NeuroPort Array just prior to pneumatic impulse insertion.
Code Information Serial # 4273-0001 through 4273-0061
Recalling Firm/
Manufacturer
I2s Micro Implantable Systems Llc
391 Chipeta Way Ste G
Salt Lake City, Utah 84108-1264
Manufacturer Reason
for Recall
Component of cranial array may not allow sufficient tightening to maintain inserter position.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, Blackrock Microsystems, sent a "RECALL" letter dated March 26, 2010, to all customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of all affected devices and promptly return any inventory, perform a physical account of your inventory for the recalled product and email a list of all serial numbers to Andrew Gotshalk at agotshalk@blackrockmicro.com, and to please email Andrew Gotshalk even if you do not have any inserter wand holders or have destroyed or removed from use the inserter wand holders. Blackrock will rework or replace all Inserter Wand Holders that is returned under this recall. If you have any questions regarding this recall please call 801-582-5533 x 275.
Quantity in Commerce 22 units
Distribution Nationwide distribution: CA, MA, NY, RI, and UT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWL and Original Applicant = CYBERKINETICS, INC. (CKI)
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