FDA Device recall Z-1612-2020
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System,…
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System,… by Trilliant Surgical, citing instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1612-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-19 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Trilliant Surgical |
| Distribution | 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 |
Product
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the label is Trilliant Surgical Ltd., Houston, TX.
Reason
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Identifiers
| code_info | (1) Trilliant Surgical Tiger Large Cannulated Screw System - IFUs previous to Document #900-01-010 Rev. I and Cleanin…(1) Trilliant Surgical Tiger Large Cannulated Screw System - IFUs previous to Document #900-01-010 Rev. I and Cleaning and Sterilization Protocols previous to Document #900-06-009 Rev. F; and (2) Trilliant Surgical Large Cannulated Headless Screw System - IFUs previous to Document 900-01-014 Rev G and Cleaning and Sterilization Protocols previous to Document #900-06-012 Rev. D. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1612-2020%22
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