The Recall Desk
HighFDA (Devices)·Z-2037-2018·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (bead separation) that could render the device discontinuous, posing a risk of harm to patients, but the source text does not report specific injuries or fatalities, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Torax Medical, Inc. is recalling the LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T. 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 affected product codes are LS-12 through LS-17, with specific part numbers and GTINs listed in the agency documentation.

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 LINX system is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed 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 violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

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; Lap
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 LS-12
  • Part No. 2170-6
  • GTIN 00855106005011
  • b. Product Code LS-13
  • Part No. 2170-7
  • GTIN 00855106005028
  • c. Product Code LS-14
  • Part No. 2170-8
  • GTIN 00855106005035
  • d. Product Code LS-15
  • Part No. 2170-9
  • GTIN 00855106005042
  • e. Product Code LS-16
  • Part No. 2170-10
  • GTIN 00855106005059
  • f. Product Code LS-17
  • Part No. 2170-11
  • GTIN 00855106005066
  • Lot No. 6100 through 14055
  • 15286

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 →

Related recalls

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Same hazard · structural defect

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