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 | Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability. |
| Product | 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion |
| Quantity | 5 drill bits |
| Distribution | US Nationwide distribution in the state of CA. OUS: None |
| Initiated | 2019-10-10 |
| Classified | 2020-05-05 |
| Terminated | 2022-04-27 |
| Recall number | Z-1892-2020 |
| 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-1892-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85374/
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