Recall Z-2603-2018 ยท NKB Thoracolumbosacral Pedicle Screw System
Medtronic Sofamor Danek USA Inc
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045
| Date | Jul 9, 2018 |
| Status | Terminated |
| Reason | This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements. |
| Root cause | Employee error |
| Action | Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees, delivered 09 July 2018. The notice stated provided a list of Loaner kits where the screws may also be found and provided the following instructions: " Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement |
| Quantity | 47 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113174 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc., Nov 21, 2011 |