FDA Medical Device Recalls (openFDA)
Cyberkinetics Neurotechnology Systems, Inc.: Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
- Recall number
- Z-1553-2009
- Recalling firm
- Cyberkinetics Neurotechnology Systems, Inc.
- Product
- Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.
- Status
- Terminated
- Initiated
- 2009-02-04
- Posted
- 2009-07-07
- Terminated
- 2009-08-20
- 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.
- Lot, serial or model codes
- Lot Number: 4468-071408.
- 510(k) numbers
- ["K042384"]
- PMA numbers
- not on file
- Product code
- GZL
- Firm FEI
- 3005346158
- Firm city
- Foxboro
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28