TYRX Inc.: Medical Device Recall in 2016 - (Recall #: Z-2540-2016)

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 Absorbable Antibacterial Envelope 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-2540-2016

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: 2993 units

Code Information:

model number CMRM6122 lot number 16E03727 16E05728 model number CMRM6133 lot number 16E02726 16E06729

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated