Class 2 Device Recall Prestige Cervical Disc System, Implant Trial

• Date Initiated by Firm: September 04, 2007
• Date Posted: December 19, 2007
• Recall Status: Terminated on November 03, 2008
• Recall Number: Z-0139-2008
• Recall Event ID: 44953
• PMA Number: P060018
• Product Classification: Cervical Disc System - Product Code MJO
• Product: Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
• Code Information: Lot Numbers: CN06M008, CN07A021, 430016, 520351, 515706, 515725, 518405, 520343, 515704, 515705, 523112, 523110, 520340, and 533001
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Place; Memphis TN 38132-1719
• For Additional Information Contact: Bert Kelly; 901-396-3133
• Manufacturer Reason for Recall: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
• FDA Determined Cause: Device Design
• Action: The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.
• Quantity in Commerce: 196 units
• Distribution: Nationwide
• 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.

• PMA Database: PMAs with Product Code = MJO