BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1553-2009 · Initiated February 4, 2009

    Recall

    Recall Number
    Z-1553-2009
    Event Number
    51951
    Firm
    Cyberkinetics Neurotechnology Systems, Inc.
    FEI Number
    3005346158
    Product Code
    GZL
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 4, 2009
    Posted
    July 7, 2009
    Terminated
    August 20, 2009
    Address
    100 Foxboro Blvd, Ste 240, Foxboro, MA, 02035-2800

    Description

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

    Reason

    Sterility of product cannot be assured

    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.

    Distribution

    Nationwide Distribution - State of MA.

    Quantity

    2 units