Z-2822-2018Class II

NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024

Name: Z-2822-2018 NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Creator: Nico Corp.
Published: 2018-06-19
License: https://open.fda.gov/license/

Nico Corporation / initiated 2018-06-19 / Terminated / root cause: packaging

FDA source

Nico Corp. began a recall of NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024 on 2018-06-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2822-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-19
Posted: 2018-08-14
Terminated: 2018-11-09
Recalling firm: Nico Corporation
Product: NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Product code: GZT Retractor, Self-Retaining, For Neurosurgery
Reason for recall: 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 tag: packaging
FDA 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 [email protected] or 317-660-7118 ext. 104.
Quantity in commerce: 204 devices
Distribution: US Nationwide distribution
Product codes and lots: Lot Number: 37LG1834 Exp. Date: 11Jan 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2822-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2822-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-14

Product code GZT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)