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 | The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through. |
| Product | 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. |
| Quantity | 121 units |
| Distribution | Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico. |
| Initiated | 2015-07-20 |
| Classified | 2015-08-24 |
| Terminated | 2017-01-26 |
| Recall number | Z-2452-2015 |
| 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-2452-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71812/
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