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U.S. Department of Health and Human Services

Class 2 Device Recall Prestige Cervical Disc System, Implant Trial

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  Class 2 Device Recall Prestige Cervical Disc System, Implant Trial see related information
Date Initiated by Firm September 04, 2007
Date Posted December 19, 2007
Recall Status1 Terminated 3 on November 03, 2008
Recall Number Z-0140-2008
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 #: 6972266, SIZE 6 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Code Information Lot Numbers: CN07A030, CN07A024, 434226, 505039, 515349, 514674, 515343, 520034, 515347, 517759, 520032, 520033, 513711, 515350 and 508115
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 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
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 and Original Applicant = MEDTRONIC SOFAMOR DANEK, INC.
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