Events

Recall of LINX Reflux Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Torax Medical, 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
    79822
  • Event Risk Class
    Class 2
  • Event Number
    Z-2039-2018
  • Event Initiated Date
    2018-04-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163590
  • 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
    Implant, anti-gastroesophageal reflux - Product Code LEI
  • Reason
    Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. this condition may result in a discontinuous or open linx device.
  • Action
    The firm, Consignees Torax Medical Inc., sent an "URGENT: FIELD SAFETY NOTICE (REMOVAL)" letter mailed on approximately 04/20/2018 (US consignees and physicians) and 04/23/2018 (OUS consignees and physicians). The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine any affected product, communicate the issue to all relevant operating room or materials management personnel, forward the recall information to facilities where the product may have been forwarded to, complete the Business Reply Form confirming receipt of this notice and return it to Torax Medical, Inc. within three (3) business days via email at brf@toraxmedical.com; ( return the BRF even if you do not have the product lot subject to this recall.), and arrange the return of any affected product on hand. Additionally, a recall notification will be sent to sent to physicians outlining the reason for recall and to advise them to monitor their patients. Question regarding the recall can be directed to the Customer Support Cetner at 1-877-384-4266, which is open Monday through Friday, 7:30 AM to 6:30 PM ET.

Device

LINX Reflux Management System
  • Model / Serial
    a. Product Code LXMC-13, Part No. 4550-13, GTIN 00855106005332;  b. Product Code LXMC-14, Part No. 4550-14, GTIN 00855106005349;  c. Product Code LXMC-15, Part No. 4550-15, GTIN 00855106005356;  d. Product Code LXMC-16, Part No. 4550-16, GTIN 00855106005363;  e. Product Code LXMC-17, Part No. 4550-17, GTIN 00855106005370;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.
  • Product Description
    LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: || a. Product Code LXMC-13; || b. Product Code LXMC-14; || c. Product Code LXMC-15; || d. Product Code LXMC-16; || e. Product Code LXMC-17; || Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
  • Manufacturer
    Torax Medical, Inc.

Manufacturer

Torax Medical, Inc.
  • Manufacturer Address
    Torax Medical, Inc., 4188 Lexington Ave N, Shoreview MN 55126-6106
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA