Class 2 Device Recall KYPHON(R) EXPRESS(TM), Osteo Introducer(R) System, Diamond and Bevel, Size 2

• Date Initiated by Firm: January 13, 2015
• Date Posted: February 05, 2015
• Recall Status: Terminated on July 13, 2015
• Recall Number: Z-1057-2015
• Recall Event ID: 70414
• Product Classification: Accessories, fixation, spinal intervertebral body - Product Code LYQ
• Product: KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
• Code Information: WI14H054
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Place; Memphis TN 38132
• For Additional Information Contact: Eric Epperson; 901-344-1435
• Manufacturer Reason for Recall: The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
• FDA Determined Cause: Process control
• Action: On January 12, 2015, the Sales Managers and Sales Force were notified by Post-Market Quality regarding the imminent notification and follow-up activities. The recall notices were delivered to the Risk Managers at impacted consignee sites on January 13, 2015. These recall notices included a Risk Manager Letter informing them on the action, and a consignee-specific questionnaire to indicate their product on-hand.
• Quantity in Commerce: 239 units
• Distribution: Nationwide and Canada
• 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.