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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Sofamor Danek Extended Length Trocar

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  Class 2 Device Recall Medtronic Sofamor Danek Extended Length Trocar see related information
Date Initiated by Firm December 07, 2009
Date Posted January 12, 2010
Recall Status1 Terminated 3 on January 14, 2011
Recall Number Z-0607-2010
Recall Event ID 54031
Product Classification trocar - Product Code LXH
Product Medtronic Sofamor Danek Extended Length Trocar, Size : L=50MM, Item No.: 7578014, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON¿ LEGACY" Percutaneous Peek Spinal System
Code Information All Codes
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Marybeth Thorsgaard
901-396-1800
Manufacturer Reason
for Recall		 The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.
FDA Determined
Cause 2		 Device Design
Action On 12/7/2009, the Sales Representatives were notified by conference call and email regarding the recall. The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included respectively, on 12/09/2009 with a delivery date of 12/10/09.
Quantity in Commerce 266
Distribution Nationwide distribution, and the Netherlands
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.
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