Class 2 Device Recall GENICON EZEE

• Date Initiated by Firm: July 19, 2017
• Create Date: March 16, 2018
• Recall Status: Terminated on May 18, 2020
• Recall Number: Z-1076-2018
• Recall Event ID: 78655
• 510(K)Number: K162059
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: GENICON EZEE Retrieval, sterile, Rx only.
• Code Information: Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.
• Recalling Firm/ Manufacturer: Genicon, Inc.; 6869 Stapoint Ct Ste 112; Winter Park FL 32792-6603
• For Additional Information Contact: 407-657-4851
• Manufacturer Reason for Recall: Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
• FDA Determined Cause: Device Design
• Action: Consignees were notified via email on 07/19/2017. Instructions included
• Quantity in Commerce: 2,967 units
• Distribution: Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
• 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.

• 510(K) Database: 510(K)s with Product Code = GCJ and Original Applicant = GENICON, INC