Class 2 Device Recall Midas Rex Legend Dissecting Tool

• Date Initiated by Firm: October 21, 2015
• Create Date: November 20, 2015
• Recall Status: Terminated on June 24, 2016
• Recall Number: Z-0321-2016
• Recall Event ID: 72541
• 510(K)Number: K020069
• Product Classification: Motor, drill, pneumatic - Product Code HBB
• Product: Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
• Code Information: Catalog Number: 16TA24, Lot Number: 0006936810
• FEI Number: 1625507
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution; 4620 N Beach St; Haltom City TX 76137-3219
• For Additional Information Contact: David Leers; 817-788-6587
• Manufacturer Reason for Recall: The wire pass hole is not present on the tools.
• FDA Determined Cause: Process control
• Action: A recall letter was mailed to consignees on October 21, 2015.
• Quantity in Commerce: 9 pieces
• Distribution: Distributed in the states of California, New York, and Texas and the country of Belgium.
• 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 = HBB