The Recall Desk

FDA (Devices) recall action 79822

Torax Medical, Inc. recalled 5 products on 2018-06-06

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-06-06
Critical
0
Units
45,655

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Sutures

    Torax Medical is recalling LINX Reflux Management System implant sutures because a manufacturing defect may cause beads to separate from wire links, potentially rendering the device discontinuous.

    Product
    LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17…
    Category
    Distribution
    47 states
  • ModerateFDA (Devices)··2018-06-06

    Torax Medical Recalls LINX Reflux Management System Devices

    Torax Medical is recalling LINX Reflux Management Systems because a bead component may separate from an adjacent wire link, potentially resulting in a discontinuous or open device.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17…
    Category
    Distribution
    47 states
  • SevereFDA (Devices)··2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    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…
    Category
    Distribution
    47 states
  • SevereFDA (Devices)··2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.

    Product
    LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure…
    Category
    Distribution
    47 states
  • SevereFDA (Devices)··2018-06-06

    Torax Medical Recalls LINX Reflux Management System Implant Clasps

    Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device discontinuous or open.

    Product
    LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17…
    Category
    Distribution
    47 states