TYRX Inc.: Medical Device Recall in 2016 - (Recall #: Z-2539-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)

Product Classification:

Class II

Date Initiated: June 29, 2016

Date Posted: August 24, 2016

Recall Number: Z-2539-2016

Event ID: 74672

Reason for Recall:

TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.

Status: Terminated

Product Quantity: 3460 units

Code Information:

model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated