Class II — Trilliant Surgical Ltd.
| Recalling firm | Trilliant Surgical |
|---|---|
| Registered facility | Trilliant Surgical LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head. |
| Product | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones. |
| Quantity | 108 units |
| Distribution | NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX |
| Initiated | 2015-07-31 |
| Classified | 2015-09-04 |
| Terminated | 2017-01-26 |
| Recall number | Z-2738-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Trilliant Surgical Ltd. (Z-2738-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71936/
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