3 — Class II medical device recall Z-1892-2020
Terminated recall by Trilliant Surgical, LLC, reported 2020-05-13, distributed nationwide. Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This c
| Recall number | Z-1892-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trilliant Surgical, LLC, Houston, TX, United States |
| Recall initiated | 2019-10-10 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2022-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 5 drill |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00812926029696 |
| Lot numbers | TSL008495A |
| Model numbers | 330-35-001 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1892-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.