TITAN SPINE, LLC: Medical Device Recall in 2012 - (Recall #: Z-0535-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 19, 2012

Date Posted: December 26, 2012

Recall Number: Z-0535-2013

Event ID: 63549

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.

Status: Terminated

Product Quantity: 92 pcs.

Code Information:

Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.

Distribution Pattern:

Nationwide Distribution including NV

Voluntary or Mandated:

Voluntary: Firm initiated