Recall Z-0210-2008 ยท LXH Orthopedic Manual Surgical Instrument
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, REF 8004208, Manufactured at: Bartlett, Tennessee, USA
| Date | Dec 22, 2007 (initiated Sep 13, 2007) |
| Status | Terminated |
| Reason | Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm. |
| 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 | 148 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.