—#82157

Product

Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.

FDA product code: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K080083
Affected lot / code info: All Lots.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132

Distribution

Distribution pattern: Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa.

Timeline

Recall initiated: 2009-02-06
Posted by FDA: 2009-07-24
Terminated: 2010-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.