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 | Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively. |
| Product | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device. |
| Quantity | 50 units |
| Distribution | Nationwide Distribution |
| Initiated | 2016-12-08 |
| Classified | 2017-01-06 |
| Terminated | 2017-05-17 |
| Recall number | Z-0960-2017 |
| 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-0960-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76029/
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