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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall KYPHON(R) EXPRESS(TM), Osteo Introducer(R) System, Diamond and Bevel, Size 2 see related information
Date Initiated by Firm January 13, 2015
Date Posted February 05, 2015
Recall Status1 Terminated 3 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/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Eric Epperson
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 2
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.