Events

Recall of Device Recall Medtronic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TYRX Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74672
  • Event Risk Class
    Class 2
  • Event Number
    Z-2539-2016
  • Event Initiated Date
    2016-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148162
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mesh, surgical, polymeric - Product Code FTL
  • Reason
    Tryx products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
  • 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.

Device

Device Recall Medtronic
  • Model / Serial
    model number  CMRM3122  lot number   15F30614 15F30614-A 15H10630 15K29659 16B05695  model number CMRM3133  lot number   15F18607 15G14620 15J29647 16C03706
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    TRYX Antibacterial Envelope Rx Only || Product Usage: || Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
  • Manufacturer
    TYRX Inc.

Manufacturer

TYRX Inc.
  • Manufacturer Address
    TYRX Inc., 1 Deerpark Dr Ste G, Monmouth Junction NJ 08852-1920
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA