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Class 2 Device Recall Prestige Cervical Disc System, Implant Trial |
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Date Initiated by Firm |
September 04, 2007 |
Date Posted |
December 19, 2007 |
Recall Status1 |
Terminated 3 on November 03, 2008 |
Recall Number |
Z-0142-2008 |
Recall Event ID |
44953 |
PMA Number |
P060018 |
Product Classification |
Cervical Disc System - Product Code MJO
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Product |
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog: 6972267, SIZE 7 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA |
Code Information |
Lot Numbers: CN07A034, CN07A031, 434185, 508110, 508111, 508108, 515701, 515702, 508112, 515686, 518409, 518410, 522181, 522179 and 522180 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Place Memphis TN 38132-1719
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For Additional Information Contact |
Bert Kelly 901-396-3133
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Manufacturer Reason for Recall |
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be imporperly seated.
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FDA Determined Cause 2 |
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
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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.
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PMA Database |
PMAs with Product Code = MJO and Original Applicant = MEDTRONIC SOFAMOR DANEK, INC.
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