Class 2 Device Recall SATELLITE Spinal System

• Date Initiated by Firm: January 14, 2006
• Date Posted: June 08, 2006
• Recall Status: Terminated 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
• FEI Number: 1000477302
• 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: 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