Recall Z-1059-2012 ยท MQP Spinal Vertebral Body Replacement Device
Lucero Medical LLC
ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfield, Ohio 44826 Product Usage: Device Description: The Enduramesh is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supp
| Date | Feb 17, 2012 (initiated Jan 11, 2012) |
| Status | Terminated |
| Reason | During an FDA inspection the firm was informed that the device marketed is not the device cleared for the 510K associated with the device. The product is sold unlabeled. |
| Root cause | Device Design |
| Action | Lucero Medical LLC made a personal visit to facilities in regards to an Urgent Medical Device Recall as of January 12, 2012. The firm instructed the customer that they were removing and quarantining all product from the facility. If you have any further questions, please contact Lucero Medical, PO Box 69, Richfield, Ohio 44826, Director of Quality Assurance/Natalie Williams/ (440) 670-9583 |
| Quantity | 190 units |
| Distribution | USA Nationwide Distribution - in the state of OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.