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Terminated

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.

FDA Recall Z-0535-2013 · Posted 2012-12-17

Recalling FirmTITAN SPINE, LLC
Recall StatusTerminated
Product CodeMQP
Date Initiated2012-10-19
Date Terminated2013-01-14
Product Quantity92 pcs.

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.

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution including NV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENTOrthovita, Inc. · 2003-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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