Date Initiated by Firm | December 07, 2009 |
Date Posted | January 12, 2010 |
Recall Status1 |
Terminated 3 on January 14, 2011 |
Recall Number | Z-0606-2010 |
Recall Event ID |
54031 |
Product Classification |
trocar - Product Code LXH
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Product | Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, 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 | 199 units |
Distribution | Nationwide distribution, and the Netherlands |
Total Product Life Cycle | TPLC Device Report |
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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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