Z-0202-2008

Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile...

Name: Z-0202-2008 Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2007-09-13
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2007-09-13 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000210, Manufactured at: Warsaw... on 2007-09-13. The reason FDA records is "Labeling, including indications for use, lack 510 (K) approval". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0202-2008
Status: Terminated
Initiated: 2007-09-13
Posted: 2007-12-22
Terminated: 2009-08-18
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000210, Manufactured at: Warsaw, Indiana, USA
Product code: NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Reason for recall: Labeling, including indications for use, lack 510 (K) approval
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On September 12, 2007, the recalling firm's representatives were instructed by electronic mail to remove any manuals in the field and contact surgeons who have evaluated, implanted or been trained to implant the Satellite System and to collect any guides they may have on site. The sales representatives that have accounts where the Satellite product was shipped directly were mailed the information and instructed to hand deliver the 9/13/07, Urgent Device Recall notices to each consignees risk management office. The recall was then expanded on 10/31/2007, to include the surgical manual, the implants and associated instruments. The delivery of the second Urgent Device Recall Notices, dated 10/25/07, were handled in three ways: 1) The letter was delivered to all initial consignees that received satellite products along with a questionnaire (response card) to be completed by the Risk Manager or equivalent administrative function., 2) The letter without the questionnaire was sent directly to target surgeons who are known to have implanted or have been trained to implant Satellite Product 3) a field action confirmation form was sent to Sales Representative with surgeon customers that are receiving the recall communication. The form will be completed by the Sales Representative to confirm the surgeons have received the recall communication and have returned any of the surgical techniques and instruments.
Quantity in commerce: 22 units
Distribution: Nationwide
Product codes and lots: ALL LOTS to include: LX52, MA67

Product code NVR

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)