Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004… recallZ-1324-2015 · Titan Spine, LLC · initiated Feb 20, 2015
Class II Terminated All recalls posted in March 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Titan Spine, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1324-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 20, 2015
- Posted by the FDA
- Mar 26, 2015
- Recalling firm
- Titan Spine, LLC
- Quantity
- 26
- Product code
- OVE
- FDA submissions
- K142940
- 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 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).
Code information (models, lots, serial numbers)
G150101
Other devices under the same FDA submission
5 devices cleared under K142940 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ENDOSKELETON® TCS 5366-1410Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical2 reports
- ENDOSKELETON® TCS 5210-1021Medtronic Sofamor Danek, Inc. · DRIVER, PROSTHESIS2 reports
- ENDOSKELETON® TCS 5210-1067Titan Spine, LLC · Orthopedic Manual Surgical Instrument1 report
- ENDOSKELETON TCS 5210-1004Titan Spine, LLC · Intervertebral fusion device with bone graft, cervical1 report
- ENDOSKELETON TCS 5210-1005Titan Spine, LLC · Intervertebral fusion device with bone graft, cervical1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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