FDA Medical Device Recalls (openFDA)
TITAN SPINE, LLC: 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.
- Recall number
- Z-0535-2013
- Recalling firm
- TITAN SPINE, LLC
- 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.
- Status
- Terminated
- Initiated
- 2012-10-19
- Posted
- 2012-12-17
- Terminated
- 2013-01-14
- Reason
- Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
- Root cause
- Labeling False and Misleading
- 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
- 92 pcs.
- Distribution
- Nationwide Distribution including NV
- Lot, serial or model codes
- Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.
- 510(k) numbers
- ["K032812"]
- PMA numbers
- not on file
- Product code
- MQP
- Firm FEI
- 3006340236
- Firm city
- Mequon
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28