Class 2 Device Recall Medtronic Midas Rex Dissecting Tool Legend

• Date Initiated by Firm: April 08, 2016
• Date Posted: May 04, 2016
• Recall Status: Terminated on February 16, 2017
• Recall Number: Z-1602-2016
• Recall Event ID: 73869
• 510(K)Number: K020069
• Product Classification: Motor, drill, pneumatic - Product Code HBB
• Product: Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
• Code Information: Product Catalog Number: 10BA40D, Lot Number: H5237248
• 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: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
• FDA Determined Cause: Labeling mix-ups
• Action: A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.
• Quantity in Commerce: 81 tools
• Distribution: Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and 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 = HBB