Titan Spine Endoskeleton TA Implant products — Class II medical device recall Z-0535-2013
Terminated recall by TITAN SPINE, LLC, reported 2012-12-26, distributed nationwide. Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this de
| Recall number | Z-0535-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TITAN SPINE, LLC, Mequon, WI, United States |
| Recall initiated | 2012-10-19 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 92 units |
| Reason classes | labeling |
| Lot numbers | 2107-0118, 2107-0120, 2107-0218, 2107-0220, A110812, A110813, A110822, A110828, A110830, A120262, A120263, A120305, A120801, A120901, A120907, A120909 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0535-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.