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U.S. Department of Health and Human Services

Class 2 Device Recall COLORADO 2" SPINAL SYSTEM

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  Class 2 Device Recall COLORADO 2" SPINAL SYSTEM see related information
Date Initiated by Firm September 10, 2007
Date Posted February 07, 2008
Recall Status1 Terminated 3 on July 14, 2009
Recall Number Z-0125-2008
Recall Event ID 44854
510(K)Number K991031  
Product Classification Spinal Implant Component - Product Code KWP
Product Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
Code Information Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
Recalling Firm/
Manufacturer		 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
2500 Silveus Crossing
Warsaw IN 46582-8598
For Additional Information Contact
877-696-5344
Manufacturer Reason
for Recall		 Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.
FDA Determined
Cause 2		 Process control
Action Medtronic Sofamor Danek notified consignees by Urgent Device Recall letter dated 9/10/07 to immediately cease using the product and to return the devices with a Product Recall Questionnaire, recording quantity of devices and any patient injuries.
Quantity in Commerce 2,569
Distribution Worldwide Distribution - USA, Australia, Hong Kong 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.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = SOFAMOR DANEK USA,INC.
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