Class 2 Device Recall FibuLock Outrigger Targeting Guide

• Date Initiated by Firm: December 17, 2019
• Create Date: January 30, 2020
• Recall Status: Terminated on August 31, 2023
• Recall Number: Z-0919-2020
• Recall Event ID: 84594
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
• Code Information: Batch/Lot 051838
• Recalling Firm/ Manufacturer: Arthrex, Inc.; 1370 Creekside Blvd; Naples FL 34108-1945
• For Additional Information Contact: Arthrex Product Surveillance Dept.; 866-297-9138
• Manufacturer Reason for Recall: There is a potential for blockage of the Hub Attachment Tube.
• FDA Determined Cause: Process control
• Action: Consignees were notified via e-mail with recall letter dated 12/17/2019. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.
• Quantity in Commerce: 47
• Distribution: Nationwide in US; no distribution OUS.
• 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.