Rappel de LINX Reflux Management System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Torax Medical, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79822
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2039-2018
  • Date de mise en oeuvre de l'événement
    2018-04-20
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Implant, anti-gastroesophageal reflux - Product Code LEI
  • Cause
    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

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Manufacturer

  • Adresse du fabricant
    Torax Medical, Inc., 4188 Lexington Ave N, Shoreview MN 55126-6106
  • Société-mère du fabricant (2017)
  • Source
    USFDA