Z-0535-2013Class II

Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm...

Name: Z-0535-2013 Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm...
Creator: Titan Spine, Llc
Published: 2012-10-19
License: https://open.fda.gov/license/

Titan Spine, LLC / initiated 2012-10-19 / Terminated / root cause: labeling and UDI

FDA source

TITAN SPINE, LLC began a recall of Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm... on 2012-10-19. FDA classified it as Class II and gives the reason as "Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0535-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-19
Posted: 2012-12-17
Terminated: 2013-01-14
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.
Product code: MQP Spinal Vertebral Body Replacement Device
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 92 pcs.
Distribution: Nationwide Distribution including NV
Product codes and lots: Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0535-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0535-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

Product code MQP

K032812Class IIEndoskeleton Ta Vertebral Body ReplacementOrthovita, Inc. / cleared 2003-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)