Recall Z-1616-2016 ยท MQP Spinal Vertebral Body Replacement Device
Atlas Spine, Inc.
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
| Date | Jul 26, 2013 |
| Status | Terminated |
| Reason | The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. |
| Root cause | Device Design |
| Action | Atlas Spine, Inc. informed all consignees of the recall and sub-recall on July 26, 2013, in person, electronically, and/or via email. Firm takes the responsibility of tracking of set return and inventory control of the product. For questions regarding this recall call 561-354-1108, ext 102. |
| Quantity | 16 |
| Distribution | Nationwide Distribution to FL, MO, and WV. |
| FDA record | Open on fda.gov |