Z-1324-2015Class II

Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS...

Name: Z-1324-2015 Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS...
Creator: Titan Spine, Llc
Published: 2015-02-20
License: https://open.fda.gov/license/

Titan Spine, LLC / initiated 2015-02-20 / Terminated / root cause: manufacturing process

FDA source

TITAN SPINE, LLC began a recall of 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... on 2015-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1324-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-20
Posted: 2015-03-26
Terminated: 2015-04-17
Recalling firm: Titan Spine, LLC
Product: 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 code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Titan Spine sent an "Urgent Medical Device Recall" letter via Fed Ex dated February 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A replacement TCS Straight Hex lobular# 6 Drivers (5210-1004) will be shipped out to each Titan Spine Area Vice President and Sales Rep. within 4-6 weeks. For further questions please call (262) 242-7801.
Quantity in commerce: 26
Distribution: 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.
Product codes and lots: G150101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1324-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1324-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-26

Product code OVE

K142940Class IIEndoskeleton TCS SystemTitan Spine, LLC / cleared 2015-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)