Recall Z-0125-2008 ยท KWP Appliance, Fixation, Spinal Interlaminal
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
| Date | Feb 7, 2008 (initiated Sep 10, 2007) |
| Status | Terminated |
| Reason | Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced. |
| Root cause | Process control |
| Action | Medtronic Sofamor Danek notified consignees by Urgent Device Recall letter dated 9/10/07 to immediately cease using the product and to return the devices with a Product Recall Questionnaire, recording quantity of devices and any patient injuries. |
| Quantity | 2,569 |
| Distribution | Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991031 | COLORADO II SPINAL SYSTEM Sofamor Danek USA,Inc., May 10, 2000 |