Home / Recalls / TITAN SPINE, LLC / Z-1324-2015

Z-1324-2015 Class II Terminated

Recalled by TITAN SPINE, LLC — Mequon, WI

Recall Details

Product Type: Devices
Report Date: April 1, 2015
Initiation Date: February 20, 2015
Termination Date: April 17, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26

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).

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.

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.

Code Information

G150101