Recall Z-1941-2020 ยท KWP Appliance, Fixation, Spinal Interlaminal
Medtronic Sofamor Danek USA Inc
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
| Date | Mar 26, 2020 |
| Status | Terminated |
| Reason | Nonconforming product; length of the product measured shorter than the labeled length. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic, Inc., notified customers on March 31, 2020 via " Urgent Voluntary Market Removal (Recall) Vertex Select Multi Axial Screw (MAS) Product Code 6958838 Lot H5517628. The recall letter identified the affected product and requested the customers to remove the impacted product from normal storage location and complete the return form. |
| Quantity | 83 units. |
| Distribution | US Nationwide distribution in the states of CA and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081297 | VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek, Jun 11, 2008 |