TITAN SPINE, LLC: Medical Device Recall in 2015 - (Recall #: Z-1324-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).

Product Classification:

Class II

Date Initiated: February 20, 2015

Date Posted: April 1, 2015

Recall Number: Z-1324-2015

Event ID: 70576

Reason for Recall:

The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.

Status: Terminated

Product Quantity: 26

Code Information:

G150101

Distribution Pattern:

US Distribution to the states of : AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT and WI.

Voluntary or Mandated:

Voluntary: Firm initiated