BEUDAMED
    FDA Recall Terminated

    Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT. Intended use: The Inserter Wand Holder serves two key functions. It firmly secures the Inserter Wand to prevent recoil during the NeuroPort Array insertion process, and it facilitates precision alignment of the Inserter Wand with respect to the back of the NeuroPort Array just prior to pneumatic impulse insertion.

    Recall: Z-1619-2010 · Initiated March 26, 2010

    Recall

    Recall Number
    Z-1619-2010
    Event Number
    55304
    Firm
    I2s Micro Implantable Systems Llc
    FEI Number
    3007323246
    Product Code
    GWL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 26, 2010
    Posted
    May 20, 2010
    Terminated
    May 25, 2010
    Address
    391 Chipeta Way, Ste G, Salt Lake City, UT, 84108-1264

    Description

    Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT. Intended use: The Inserter Wand Holder serves two key functions. It firmly secures the Inserter Wand to prevent recoil during the NeuroPort Array insertion process, and it facilitates precision alignment of the Inserter Wand with respect to the back of the NeuroPort Array just prior to pneumatic impulse insertion.

    Reason

    Component of cranial array may not allow sufficient tightening to maintain inserter position.

    Action

    The firm, Blackrock Microsystems, sent a "RECALL" letter dated March 26, 2010, to all customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of all affected devices and promptly return any inventory, perform a physical account of your inventory for the recalled product and email a list of all serial numbers to Andrew Gotshalk at [email protected], and to please email Andrew Gotshalk even if you do not have any inserter wand holders or have destroyed or removed from use the inserter wand holders. Blackrock will rework or replace all Inserter Wand Holders that is returned under this recall. If you have any questions regarding this recall please call 801-582-5533 x 275.

    Distribution

    Nationwide distribution: CA, MA, NY, RI, and UT.

    Quantity

    22 units