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Terminated

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

FDA Recall Z-1553-2009 · Posted 2009-07-07

Recalling FirmCyberkinetics Neurotechnology Systems, Inc.
Recall StatusTerminated
Product CodeGZL
Date Initiated2009-02-04
Date Terminated2009-08-20
Product Quantity2 units

Reason for Recall

Sterility of product cannot be assured

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution - State of MA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042384NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEMCyberkinetics, Inc. (Cki) · 2005-03-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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