Recall Z-1619-2010 ยท GWL Amplifier, Physiological Signal
I2s Micro Implantable Systems Llc
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
| Date | May 20, 2010 (initiated Mar 26, 2010) |
| Status | Terminated |
| Reason | Component of cranial array may not allow sufficient tightening to maintain inserter position. |
| Root cause | Device Design |
| 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 agotshalk@blackrockmicro.com, 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 holder |
| Quantity | 22 units |
| Distribution | Nationwide distribution: CA, MA, NY, RI, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042384 | NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM Cyberkinetics, Inc. (Cki), Mar 29, 2005 |