# FDA recall Z-1892-2020

> **Trilliant Surgical, LLC** · Class II · device recall initiated 2019-10-10.

## 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.

## Distribution

US Nationwide distribution in the state of CA. OUS: None

## Key facts

- **Recall number:** Z-1892-2020
- **Recalling firm:** Trilliant Surgical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-10
- **Report date:** 2020-05-13
- **Termination date:** 2022-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Houston, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2020

## Citation

> AI Analytics. FDA recall Z-1892-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1892-2020. Source: US FDA. Licensed CC0.

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