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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 Posting Updated December 19, 2007
Recall Status1 Terminated 3 on November 03, 2008
Recall Number Z-0141-2008
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 #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Code Information Lot Numbers: CN06M012, CN07A025, 434167, 510185, 511648, 510180, 511650, 510189, 515311, 513692, 521191, 523113, 421195 and 521188
Recalling Firm/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132-1719
For Additional Information Contact Bert Kelly
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.