Class II — Trilliant Surgical, LLC
| Recalling firm | Trilliant Surgical |
|---|---|
| Registered facility | Trilliant Surgical LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended. |
| Product | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal. |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None |
| Initiated | 2019-03-14 |
| Classified | 2020-01-10 |
| Terminated | 2022-03-16 |
| Recall number | Z-0799-2020 |
| 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, LLC (Z-0799-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84350/
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