# FDA recall Z-1606-2020

> **Trilliant Surgical, LLC** · Class II · device recall initiated 2018-07-19.

## Product

Instructions for Use and Surgical Cleaning and Sterilization Protocol for:    (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and    (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101.    The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

## Reason for recall

Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters.  This recall of IFU occurred in 2018.

## Distribution

Distribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI,  MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR.  There was government distribution and no military distribution.    Foreign distribution to Australia, India, Italy, Panama, and Turkey.

## Key facts

- **Recall number:** Z-1606-2020
- **Recalling firm:** Trilliant Surgical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-19
- **Report date:** 2020-04-08

- **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-1606-2020

## Citation

> AI Analytics. FDA recall Z-1606-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1606-2020. Source: US FDA. Licensed CC0.

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