Recall Z-0074-2008 ยท KWP Appliance, Fixation, Spinal Interlaminal
Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131
| Date | Dec 13, 2007 (initiated Aug 24, 2007) |
| Status | Terminated |
| Reason | Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws. |
| Root cause | Device Design |
| Action | Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced. |
| Quantity | 20 units |
| Distribution | Worldwide Distribution - USA, The Netherlands, Australia, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052144 | TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Aug 31, 2005 |