Class 2 Device Recall NICO Shepherds Hook Greenberg

• Date Initiated by Firm: June 19, 2018
• Create Date: August 14, 2018
• Recall Status: Terminated on November 09, 2018
• Recall Number: Z-2822-2018
• Recall Event ID: 80540
• Product Classification: neurosurgical retractor - Product Code GZT
• Product: NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
• Code Information: Lot Number: 37LG1834 Exp. Date: 11Jan 2020
• FEI Number: 3007456622
• Recalling Firm/ Manufacturer: Nico Corp.; 250 E 96th St Ste 125; Indianapolis IN 46240-3872
• Manufacturer 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
• FDA Determined 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 in Commerce: 204 devices
• Distribution: US Nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.