Z-1803-2009

Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF...

Name: Z-1803-2009 Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2009-02-06
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2009-02-06 / Terminated / root cause: design

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM... on 2009-02-06. The reason FDA records is "The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment". 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-1803-2009
Status: Terminated
Initiated: 2009-02-06
Posted: 2009-07-24
Terminated: 2010-04-19
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx only, MATL: TITANIUM ALLOY, Manufactured at: Warsaw, Indiana USA. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic Sofamor Danek USA, Inc. instructed Sales Representative on starting February 6, 2009 by phone to immediately return product from the field. The firm further issued a "Subject: Medtronic Intrepid Intervertebral Body Fusion Device Recall" notice dated April 2009. The recall notices were mailed directly to Risk Managers and Surgeons, with Recall Questionnaires and Surgeon Confirmation forms included respectively. For further questions, contact your Medtronic Sales Representative or the Medtronic Global Quality Department at 1-800-876-3133 extension 6333.
Quantity in commerce: 4547 units
Distribution: Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa.
Product codes and lots: All Lots.

Product code MAX

K080083Class IIIntrepid Spinal SystemMedtronic Sofamor Danek / cleared 2008-04-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)