Device Recall component of NeuroPort Array brain monitoring device.

Serial # 4273-0001 through 4273-0061

Neurological Devices

2

No

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

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.