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U.S. Department of Health and Human Services

Class 2 Device Recall Cyberkinetics Inserter Wand & V2 Trigger Assembly

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  Class 2 Device Recall Cyberkinetics Inserter Wand & V2 Trigger Assembly see related information
Date Initiated by Firm February 04, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on August 20, 2009
Recall Number Z-1553-2009
Recall Event ID 51951
510(K)Number K042384  
Product Classification Electrode, depth - Product Code GZL
Product Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
Code Information Lot Number: 4468-071408. 
Recalling Firm/
Manufacturer		 Cyberkinetics Neurotechnology Systems, Inc.
100 Foxboro Blvd Ste 240
Foxboro MA 02035-2800
For Additional Information Contact
801-582-5533 Ext. 235
Manufacturer Reason
for Recall		 Sterility of product cannot be assured
FDA Determined
Cause 2		 Packaging process control
Action Cyberkinetics Neurology Systems (CKI) notified the Distributor, Blackrock Microsystem, of the affected device. Blackrock notified the final user by email on February 4, 2009.
Quantity in Commerce 2 units
Distribution Nationwide Distribution - State of MA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GZL and Original Applicant = CYBERKINETICS, INC. (CKI)
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