Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004 Recalled by TITAN SPINE, LLC Due to The TCS Straight Hexlobular #6 Drivers (5210-1004) tip...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TITAN SPINE, LLC directly.
Affected Products
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).
Quantity: 26
Why Was This 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.
Where Was This Sold?
This product was distributed to 18 states: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT, WI
About TITAN SPINE, LLC
TITAN SPINE, LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report