Z-0535-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2012
- Initiation Date
- October 19, 2012
- Termination Date
- January 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92 pcs.
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.
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.
Distribution Pattern
Nationwide Distribution including NV
Code Information
Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.