Recall Z-1796-2009 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medtronic Sofamor Danek USA Inc
Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
| Date | Jul 24, 2009 (initiated Feb 6, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 637 units |
| Distribution | Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080083 | INTREPID SPINAL SYSTEM Medtronic Sofamor Danek, Apr 10, 2008 |