Z-1088-06

8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral...

Name: Z-1088-06 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2006-01-14
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2006-01-14 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion) on 2006-01-14. The reason FDA records is "Device distribution without marketing clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1088-06
Status: Terminated
Initiated: 2006-01-14
Posted: 2006-06-08
Terminated: 2007-10-15
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion)
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Device distribution without marketing clearance
FDA root cause: Other
Action: The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use.
Quantity in commerce: 1 unit
Distribution: LA
Product codes and lots: Cat No. 8000208, Lot No. W05K0555

Product code MAX

K051320Class IIISatellite Spinal SystemMedtronic Sofamor Danek / cleared 2005-09-09

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)