| | Class 2 Recall
Titan Spine Endoskeleton TA Implant |  |
| Date Posted |
December 17, 2012 |
| Recall Number |
Z-0535-2013 |
| Product |
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 tumor or trauma. |
| Code Information |
Model # / Lot #
2107-0118: A110822, A120907.
2107-0120 : A110812, A110830, A120263, A120909.
2107-0218: A110813.
2107-0220: A110828, A120262, A120305, A120801, A120901.
|
Recalling Firm/
Manufacturer |
TITAN SPINE, LLC
6140 W Executive Dr
Suite A
Mequon, Wisconsin 53092-4499 |
Reason for
Recall |
Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
|
| 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 in Commerce |
92 pcs. |
| Distribution |
Nationwide Distribution including NV |
| |
|
|
|
|
