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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 Recall
Prestige Cervical Disc System, Implant Trial
see related information
Date Posted December 19, 2007
Recall Status1 Terminated on November 03, 2008
Recall Number Z-0140-2008
Recall Event ID 44953
Premarket Approval
PMA Number
P060018
Product Classification Prosthesis, Intervertebral Disc - 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, Tennessee 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MJO and Applicant = MEDTRONIC SOFAMOR DANEK, INC.
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