# FDA recall Z-1635-2020

> **Trilliant Surgical, LLC** · Class II · device recall initiated 2019-11-04.

## Product

8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel,  Sterile: R, PX only, UDI: (01)00812926022345(17)231225  (10)TSL007202

## Reason for recall

The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.

## Distribution

Distributors in  21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.

## Key facts

- **Recall number:** Z-1635-2020
- **Recalling firm:** Trilliant Surgical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-04
- **Report date:** 2020-04-08
- **Termination date:** 2021-04-28

- **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-1635-2020

## Citation

> AI Analytics. FDA recall Z-1635-2020. Retrieved 2026-06-29 from https://api.ai-analytics.org/recall/Z-1635-2020. Source: US FDA. Licensed CC0.

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