Recall Z-2368-2012 ยท MQP Spinal Vertebral Body Replacement Device
Lucero Medical LLC
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on s
| Date | Sep 11, 2012 (initiated Jul 15, 2012) |
| Status | Terminated |
| Reason | The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation. |
| Root cause | Error in labeling |
| Action | Lucero Medical sent a Field Correction Notice letter dated July 15, 2012 to it's sole consignee. The notice identified the affected product., problem and actions to be taken. The customer was instructed to complete the response card and submit back to their local Lucero Medical Representative. |
| Quantity | 169 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093207 | ENDURAMESH, MODEL 762.XXX Lucero Medical, LLC, Apr 26, 2010 |