Recall Z-0535-2013 ยท MQP Spinal Vertebral Body Replacement Device
TITAN SPINE, LLC
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tu
| Date | Dec 17, 2012 (initiated Oct 19, 2012) |
| Status | Terminated |
| Reason | Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use. |
| Root cause | Labeling False and Misleading |
| Action | Titan sent an Urgent Medical Device Recall letter dated October 19, 2012, to all affected customers. The letter described the problem , the product affected and the corrective measures to be taken. Customers were instructed to review any surgeries that were performed at the L5-51 level with the affected device. Customers were asked to communicate any complications associated with those cases to Titan Spine. Customers with questions should call 1-262-242-7801. For questions regarding this recall call 262-242-7801. |
| Quantity | 92 pcs. |
| Distribution | Nationwide Distribution including NV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032812 | ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT Orthovita, Inc., Dec 8, 2003 |