FDA Medical Device Recalls (openFDA)
TYRX Inc.: TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
- Recall number
- Z-2539-2016
- 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)
- Status
- Terminated
- Initiated
- 2016-06-29
- Posted
- not on file
- Terminated
- 2017-12-12
- Reason
- TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
- 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 RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 Attention Customer Focused Quality.
- Quantity
- 3460 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706
- 510(k) numbers
- ["K063091"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3005619263
- Firm city
- Monmouth Junction
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28