Food, drugs, devices › TITAN SPINE, LLC
Device recall: Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spi
TITAN SPINE, LLC (Mequon, WI) initiated this device recall on 20 Jul 2015; FDA lists 1 product record under event 71740, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 20 Oct 2015. Initiation: voluntary: firm initiated. TITAN SPINE, LLC has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
TITAN SPINE, LLC, Mequon, WI.
Reason for recall
"Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'."
Distribution
"Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2327-2015 | 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… | 137 units | Class II | Terminated | 12 Aug 2015 |
Context
Other enforcement events for TITAN SPINE, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Feb 2015 | Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is on | Device | Class II | 1 |
| 19 Oct 2012 | Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard E | Device | Class II | 1 |
All 3 events for TITAN SPINE, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Oct 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.