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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 Assemblysee related information
Date Initiated by FirmFebruary 04, 2009
Date PostedJuly 07, 2009
Recall Status1 Terminated 3 on August 20, 2009
Recall NumberZ-1553-2009
Recall Event ID 51951
510(K)NumberK042384 
Product Classification Electrode, depth - Product Code GZL
ProductCyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
Code Information Lot Number: 4468-071408. 
FEI Number 3005346158
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
ActionCyberkinetics 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 Commerce2 units
DistributionNationwide Distribution - State of MA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GZL
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