The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2040-2018·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this recall as Class II, which typically involves products that might cause temporary health problems or pose a slight threat of a serious nature. No illnesses or injuries have been reported in the source text.

Plain-English summary

Torax Medical, Inc. is voluntarily recalling the LINX Reflux Management System Implant Clasp (Product Code LX-xx) due to a possible out-of-specification condition. This defect may allow a bead component to separate from an adjacent wire link, which could result in a discontinuous or open LINX device.

The recall affects 9,131 devices distributed nationwide in the United States and in Austria, France, Germany, Italy, Scotland, Spain, Switzerland, and the United Kingdom. Affected products are sterile, prescription-only implant clamps labeled as Product Codes LX-12 through LX-17 with specific part numbers and GTINs. The affected lot numbers range from 6100 through 14055, plus lots 15286, 15287, 15314, 15315, 15317, and 16557.

The LINX device is indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) who are seeking an alternative to continuous acid suppression therapy. The FDA has classified this recall as Class II.

The recalled product

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…
Manufacturer
Torax Medical, Inc.
Category
Medical Device — Gastroesophageal Reflux Disease Implant
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 LX-12
  • Part No. 2684-12
  • GTIN 00855106005073
  • b. Product Code LX-13
  • Part No. 2684-13
  • GTIN 00855106005080
  • c. Product Code LX-14
  • Part No. 2684-14
  • GTIN 00855106005097
  • d. Product Code LX-15
  • Part No. 2684-15
  • GTIN 00855106005103
  • e. Product Code LX-16
  • Part No. 2684-16
  • GTIN 00855106005110
  • f. Product Code LX-17
  • Part No. 2684-17
  • GTIN 00855106005127
  • 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 →

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