Recall Z-1750-2018 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Medtronic Sofamor Danek USA Inc
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
| Date | Mar 23, 2018 |
| Status | Terminated |
| Reason | Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. |
| Root cause | Process control |
| Action | The firm initiated their recall by letter on 03/23/2018. The recall notice requested: "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 of affected product. " |
| Quantity | 39 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141632 | ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek USA, Inc., Dec 4, 2014 |