FDA Device recall Z-0535-2013
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant…
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant… by Titan Spine, citing titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0535-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-19 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Titan Spine |
| Distribution | US |
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.
Reason
Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
Identifiers
| code_info | Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813.…Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2013%22
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