Recall Z-0465-2012 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Medtronic Sofamor Danek USA Inc
CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation
| Date | Jan 11, 2012 (initiated Nov 30, 2011) |
| Status | Terminated |
| Reason | One screw may be longer then size etched on the screw. |
| Root cause | Mixed-up of materials/components |
| Action | Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 |
| Quantity | 30 units |
| Distribution | Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042025 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc., Aug 25, 2004 |