Instructions for Use and Surgical Cleaning and Sterilization Protocol… — Class II medical device recall Z-1609-2020
Terminated recall by Trilliant Surgical, LLC, reported 2020-04-08, distributed in AZ, CA, CT, FL, GA, IA, IL, IN…. Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time par
| Recall number | Z-1609-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trilliant Surgical, LLC, Houston, TX, United States |
| Recall initiated | 2018-07-19 |
| Classified | 2020-03-30 |
| Reported by FDA | 2020-04-08 |
| Distributed | AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, PR, SD, TN, TX, VA, WA, WI, WY |
| Countries outside the US | AU, IN, IT, PA, TR |
| Quantity | 8 systems |
| Model numbers | 310-01-100 |
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. 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.
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-1609-2020. 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.