• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Prestige Cervical Disc System, Implant Trial

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
 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-0139-2008
Recall Event ID 44953
Premarket Approval
PMA Number
Product Classification Prosthesis, Intervertebral Disc - 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/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis, Tennessee 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
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.