Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
FDA device recall Z-1553-2009 · posted 2009-07-07 · Terminated
Recall details
- Recalling firm
- Cyberkinetics Neurotechnology Systems, Inc.
- Reason for recall
- Sterility of product cannot be assured
- Action taken
- Cyberkinetics Neurology Systems (CKI) notified the Distributor, Blackrock Microsystem, of the affected device. Blackrock notified the final user by email on February 4, 2009.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GZL
- Quantity affected
- 2 units
- Distribution
- Nationwide Distribution - State of MA.
- Date initiated
- 2009-02-04
- Date posted
- 2009-07-07
- Date terminated
- 2009-08-20
- Location
- Foxboro, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM (K042384) | Cyberkinetics, Inc. (Cki) | 2005-03-29 |