Titan Spine Endoskeleton Locking Bone Screw Assembly, which… recallZ-2327-2015 · Titan Spine, LLC · initiated Jul 20, 2015
Class II Terminated All recalls posted in August 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Titan Spine, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2327-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 20, 2015
- Posted by the FDA
- Aug 3, 2015
- Recalling firm
- Titan Spine, LLC
- Quantity
- 137 units
- Product code
- OVE
- FDA submissions
- K142940
- Distribution
- Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Product description
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.
Code information (models, lots, serial numbers)
Lot numbers: V03, V05, V06
Other devices under the same FDA submission
5 devices cleared under K142940 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ENDOSKELETON® TCS 5366-1410Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical2 reports
- ENDOSKELETON® TCS 5210-1021Medtronic Sofamor Danek, Inc. · DRIVER, PROSTHESIS2 reports
- ENDOSKELETON® TCS 5210-1067Titan Spine, LLC · Orthopedic Manual Surgical Instrument1 report
- ENDOSKELETON TCS 5210-1004Titan Spine, LLC · Intervertebral fusion device with bone graft, cervical1 report
- ENDOSKELETON TCS 5210-1005Titan Spine, LLC · Intervertebral fusion device with bone graft, cervical1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page