Class 2 Device Recall Drill Bit, Cannulated, 5.0 mm

• Date Initiated by Firm: February 24, 2021
• Create Date: March 26, 2021
• Recall Status: Terminated on May 02, 2023
• Recall Number: Z-1310-2021
• Recall Event ID: 87481
• Product Classification: Bit, drill - Product Code HTW
• Product: Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
• Code Information: Product Code AR-8770-02, Lot Number 032052
• Recalling Firm/ Manufacturer: Arthrex, Inc.; 1370 Creekside Blvd; Naples FL 34108-1945
• For Additional Information Contact: Arthrex Product Surveillance Dept.; 866-267-9138
• Manufacturer Reason for Recall: The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
• FDA Determined Cause: Under Investigation by firm
• Action: Consignees were notified via e-mail with URGENT: RECALL NOTIFICATION dated 02/23/2021. 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: 9 units
• Distribution: US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
• 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.