FDA Medical Device Recalls (openFDA)
Nico Corp.: NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
- Recall number
- Z-2822-2018
- Recalling firm
- Nico Corp.
- Product
- NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
- Status
- Terminated
- Initiated
- 2018-06-19
- Posted
- not on file
- Terminated
- 2018-11-09
- Reason
- Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
- Root cause
- Packaging process control
- Action
- On June 19, 2018 , NICO issued letter by mail and/or email letters to consignees that have received hooks from the affected lot. The letter provides instructions to inspect all of its current stock of NN-8024, Greenberg Hooks for the proper pouch label. if an incorrect label is discovered, the hook should be removed from stock and returned to NICO. Questions or need additional information, please contact jay.dittman@.niconeuro.com or 317-660-7118 ext. 104.
- Quantity
- 204 devices
- Distribution
- US Nationwide distribution
- Lot, serial or model codes
- Lot Number: 37LG1834 Exp. Date: 11Jan 2020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GZT
- Firm FEI
- 3007456622
- Firm city
- Indianapolis
- Firm state
- IN
- 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