Z-1553-2009

Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468

Name: Z-1553-2009 Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468
Creator: Cyberkinetics Neurotechnology Systems, Inc.
Published: 2009-02-04
License: https://open.fda.gov/license/

Cyberkinetics Neurotechnology Systems, Inc. / initiated 2009-02-04 / Terminated / root cause: packaging

FDA source

Cyberkinetics Neurotechnology Systems, Inc. began a recall of Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468 on 2009-02-04. The reason FDA records is "Sterility of product cannot be assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1553-2009
Status: Terminated
Initiated: 2009-02-04
Posted: 2009-07-07
Terminated: 2009-08-20
Recalling firm: Cyberkinetics Neurotechnology Systems, Inc.
Product: Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
Product code: GZL Electrode, Depth
Reason for recall: Sterility of product cannot be assured
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Lot Number: 4468-071408.

Product code GZL

K042384Class IINeuroport Recording Microelectrode Array SystemCyberkinetics, Inc. (Cki) / cleared 2005-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)