Z-2327-2015Class II

Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion...

Name: Z-2327-2015 Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion...
Creator: Titan Spine, Llc
Published: 2015-07-20
License: https://open.fda.gov/license/

Titan Spine, LLC / initiated 2015-07-20 / Terminated / root cause: manufacturing process

FDA source

TITAN SPINE, LLC began a recall of Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product... on 2015-07-20. FDA classified it as Class II and gives the reason as "Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2327-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Posted: 2015-08-03
Terminated: 2015-10-20
Recalling firm: Titan Spine, LLC
Product: Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Reason for recall: Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. The letters described the problem and the product involved in the recall. Advised consignees to complete and return the enclosed response form. For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. Distributors were advised to examine their inventory and quarantine the product. If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information.
Quantity in commerce: 137 units
Distribution: Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Product codes and lots: Lot numbers: V03, V05, V06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2327-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2327-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-03

Product code OVE

K142940Class IIEndoskeleton TCS SystemTitan Spine, LLC / cleared 2015-01-28

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)