Device recall
Z-2539-2016: TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization…
FDA device recall · Class II · TYRX Inc.
Key facts
| Recall number (Z-number) | Z-2539-2016 |
|---|---|
| Recall event | 74672 |
| Product | TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) |
| Product code | FTL |
| Recalling firm | TYRX Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2017 |
| 510(k) numbers | K063091 |
| FEI number | 3005619263 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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