Z-0139-2008

Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14...

Name: Z-0139-2008 Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2007-09-04
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2007-09-04 / Terminated / root cause: design

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14, MATL: Stainless Steel/Titanium, Rx only... on 2007-09-04. The reason FDA records is "Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0139-2008
Status: Terminated
Initiated: 2007-09-04
Posted: 2007-12-19
Terminated: 2008-11-03
Recalling firm: Medtronic Sofamor Danek USA Inc
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
Product code: MJO Prosthesis, Intervertebral Disc
Reason for recall: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Lot Numbers: CN06M008, CN07A021, 430016, 520351, 515706, 515725, 518405, 520343, 515704, 515705, 523112, 523110, 520340, and 533001

Product code MJO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)