Titan Spine Endoskeleton Locking Bone Screw Assembly — Class II medical device recall Z-2327-2015
Terminated recall by TITAN SPINE, LLC, reported 2015-08-12, distributed in CA, GA, IN, MA, NY, OK, OR, TX. Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking b
| Recall number | Z-2327-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TITAN SPINE, LLC, Mequon, WI, United States |
| Recall initiated | 2015-07-20 |
| Classified | 2015-08-03 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2015-10-20 |
| Distributed | CA, GA, IN, MA, NY, OK, OR, TX |
| Quantity | 137 units |
| Lot numbers | V03, V05, V06 |
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.
Reason for recall
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2327-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.