Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004 — Class II medical device recall Z-1324-2015
Terminated recall by TITAN SPINE, LLC, reported 2015-04-01, distributed in AZ, CA, CT, FL, GA, ID, IL, KY…. The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved pati
| Recall number | Z-1324-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TITAN SPINE, LLC, Mequon, WI, United States |
| Recall initiated | 2015-02-20 |
| Classified | 2015-03-26 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2015-04-17 |
| Distributed | AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT, WI |
| Quantity | 26 |
| Reason classes | device malfunction |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1324-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.