Recall Z-1553-2009 ยท GZL Electrode, Depth
Cyberkinetics Neurotechnology Systems, Inc.
Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
| Date | Jul 7, 2009 (initiated Feb 4, 2009) |
| Status | Terminated |
| Reason | Sterility of product cannot be assured |
| Root cause | Packaging process control |
| 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. |
| Quantity | 2 units |
| Distribution | Nationwide Distribution - State of MA. |
| 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 |