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U.S. Department of Health and Human Services

Class 2 Device Recall TSRH SiLo 5.5 Spinal System

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  Class 2 Device Recall TSRH SiLo 5.5 Spinal System see related information
Date Initiated by Firm August 24, 2007
Date Posted December 13, 2007
Recall Status1 Terminated 3 on August 21, 2009
Recall Number Z-0074-2008
Recall Event ID 44787
510(K)Number K052144  
Product Classification Pedicle Screw Fixation System - Product Code KWP
Product Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131
Code Information Lot Numbers: 1964441, 2633734, 14372033, 1813832, 2751495, 14673943, 14178935, 14013412, 14013714, 14013977, 14014230, 14014405, 14011615, 14011836, 15001233, 15001383, 13990466, 14103373, 14103376.
Recalling Firm/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132-1719
For Additional Information Contact Bert Kelly
Manufacturer Reason
for Recall
Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.
FDA Determined
Cause 2
Device Design
Action Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced.
Quantity in Commerce 20 units
Distribution Worldwide Distribution - USA, The Netherlands, Australia, 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.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = MEDTRONIC SOFAMOR DANEK