Recall Z-0192-2008 ยท NVR Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Medtronic Sofamor Danek USA Inc
Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Medtronic Sofamor Danek, Medtronic, Memphis, TN 38132
| Date | Dec 22, 2007 (initiated Sep 13, 2007) |
| Status | Terminated |
| Reason | Surgical manual lacks information required as a condition of the 510(k) approval. |
| 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 imp |
| Quantity | approxmately 200 to 300 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051320 | SATELLITE SPINAL SYSTEM Medtronic Sofamor Danek, Sep 9, 2005 |