Z-2539-2016Class II

TRYX Antibacterial Envelope Rx Only

Name: Z-2539-2016 TRYX Antibacterial Envelope Rx Only
Creator: TYRX Inc.
Published: 2016-06-29
License: https://open.fda.gov/license/

TYRX Inc. / initiated 2016-06-29 / Terminated / root cause: manufacturing process

FDA source

TYRX Inc. began a recall of TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators... on 2016-06-29. FDA classified it as Class II and gives the reason as "TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2539-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-29
Posted: 2016-08-15
Terminated: 2017-12-12
Recalling firm: TYRX Inc.
Product: TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter identified the affected product problem and actions to be taken. Customers are asked to immediately remove and quarantine all unused product that remains in inventory, return unused product to Medtronic and contacted the local Medtronic representative or Customer Service at 800-848-9300 to assist with the return and credit of unused product. Medtronic will provide credit for all non-expired, unused product. The customer should complete the attached Customer Confirmation Certificate and email to [email protected] or fax to Medtronic at 651-367-0612 Attention Customer Focused Quality.
Quantity in commerce: 3460 units
Distribution: US Nationwide Distribution
Product codes and lots: model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2539-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2539-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-15
Z-2540-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-15
Z-2541-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-15

Product code FTL

K063091Class IIPivit Crm (Tyrx Antimicrobial Pacemaker Pouch), Model Cmrm-0601Tyrx Pharma, Inc. / cleared 2008-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)