Device recall
Z-1611-2020: Instructions for Use and Surgical Cleaning and Sterilization Protocol for…
FDA device recall · Class II · Trilliant Surgical, LLC
Key facts
| Recall number (Z-number) | Z-1611-2020 |
|---|---|
| Recall event | 84977 |
| Product | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX. |
| Product code | HWC |
| Recalling firm | Trilliant Surgical, LLC |
| Recall class | Class II |
| Status | Terminated |
| 510(k) numbers | K072922 |
| FEI number | 3007420745 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database