FDA Device recall Z-1324-2015
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instrument…
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II 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 instrument… by Titan Spine, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1324-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-20 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Titan Spine |
| Distribution | AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT, WI |
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).
Reason
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.
Identifiers
| code_info | G150101 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1324-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.