FDA Medical Device Recalls (openFDA)
TITAN SPINE, LLC: 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.
- Recall number
- Z-2327-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-07-20
- Posted
- 2015-08-03
- Terminated
- 2015-10-20
- Reason
- Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
- 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
- 137 units
- Distribution
- Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
- Lot, serial or model codes
- Lot numbers: V03, V05, V06
- 510(k) numbers
- ["K142940"]
- PMA numbers
- not on file
- Product code
- OVE
- 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