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U.S. Department of Health and Human Services

Class 2 Device Recall SATELLITE Spinal System

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  Class 2 Device Recall SATELLITE Spinal System see related information
Date Initiated by Firm January 14, 2006
Date Posted June 08, 2006
Recall Status1 Terminated 3 on October 15, 2007
Recall Number Z-1088-06
Recall Event ID 35261
510(K)Number K051320  
Product Classification Spinal fixation device - Product Code MAX
Product 8mm SATELLITE¿ Sphere CoCr contained in a SATELLITE¿ Spinal System (internal fixation device-vertebral stabilization/fusion)
Code Information Cat No. 8000208, Lot No. W05K0555
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1719
For Additional Information Contact Bert Kelly
901-396-3133
Manufacturer Reason
for Recall		 Device distribution without marketing clearance
FDA Determined
Cause 2		 Other
Action The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use.
Quantity in Commerce 1 unit
Distribution LA
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 = MAX and Original Applicant = MEDTRONIC SOFAMOR DANEK
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