Recall Z-2822-2018 ยท GZT Retractor, Self-Retaining, For Neurosurgery
Nico Corp.
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
| Date | Jun 19, 2018 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.