FDA Device recall Z-2541-2016
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable ca…
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable ca… by Tyrx, citing TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2541-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-29 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tyrx |
| Distribution | US |
Product
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Identifiers
| code_info | model number NMRM6122 lot number 16E03727 16E05728 model number NMRM6133 lot number 16E02726 16E09730 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2541-2016%22
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