The Recall Desk
SevereFDA (Devices)·Z-2039-2018·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or structural defect (bead separation leading to an open device) are rated as Severe (4).

Plain-English summary

Torax Medical, Inc. is recalling LINX Reflux Management System Implant Clasps (Product Codes LXMC-13 through LXMC-17). The recall involves 9,131 devices distributed nationwide in the United States and in several countries in Europe, including Austria, France, Germany, Italy, Scotland, Spain, Switzerland, and the United Kingdom.

The recall is due to a possible out-of-specification condition that may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device. The affected devices are sterile, prescription-only implants indicated for patients with Gastroesophageal Reflux Disease (GERD) who are seeking an alternative to continuous acid suppression therapy.

Patients who have had this device implanted should contact their healthcare provider for evaluation and guidance. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.

The recalled product

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, fu
Manufacturer
Torax Medical, Inc.
Category
Medical Device — Implantable Device
Hazard
Affected units
9,131

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Torax Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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