8mm HTR Sterile Hammer Toe Reaming Kit — Class II medical device recall Z-1635-2020
Terminated recall by Trilliant Surgical, LLC, reported 2020-04-08, distributed in AR, AZ, CA, FL, GA, IA, IN, KS…. The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect c
| Recall number | Z-1635-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trilliant Surgical, LLC, Houston, TX, United States |
| Recall initiated | 2019-11-04 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2021-04-28 |
| Distributed | AR, AZ, CA, FL, GA, IA, IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, WI |
| Quantity | 117 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00812926022345 |
| Lot numbers | TSL007202 |
| Model numbers | 220-08-003 |
| Expiration dates | 2023-12-25 |
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.
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-1635-2020. 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.